Predicate Device Vigilance in Action: (Part 2)

Predicate Device Vigilance in Action: A Real-World Case Study for Infusion Pumps (Product Code FRN)

Introduction: What Predicate Device Vigilance Really Means Under QMSR

As the FDA’s new Quality Management System Regulation (QMSR) moves the industry into a fully risk-based and ISO 13485–aligned model, manufacturers can no longer rely solely on internal complaint data to protect patients and support compliance.

The new expectation is clear:
Post-Market Surveillance must include continuous monitoring of external devices — specifically, predicate and competitor devices that share technology, materials, components, or risk profiles.

This practice is known as Predicate Device Vigilance, and it is one of the most powerful ways to prevent future failures and cut latent risks before they surface in your own products.

In my earlier article titled Post-Market Surveillance Under the New QMSR: Corrective vs Preventive Actions and Predicate Device Vigilance, I explored how PMS (Postmarket Surveillance) connects with corrective and preventive action requirements under QMSR and explains why monitoring predicate and competitor devices can serve as a powerful source of preventive action.

In this case study, I walk through how to perform Predicate Device Vigilance for a commonly regulated product:
an infusion pump (Product Code FRN).

1. Step One: Find the Product Code and Predicate Devices

The FDA explains that the most effective way to find predicate devices is by using the product code (“procode”), found in the Product Code Classification Database.

For an infusion pump, the FDA classification search returns:

Product Code: FRN
Device Name: Pump, Infusion
Regulation: 21 CFR 880.5725
Class: II

This is our anchor.

Finding Predicates in the 510(k) Database

Using the FRN product code in the 510(k) database yields all FDA-cleared infusion pumps — including legacy models and current competitor devices.

These become the basis for Predicate Device Vigilance.

2. Step Two: Perform Predicate Device Vigilance

Once predicate and competitor devices are identified, we evaluate their field performance across FDA information sources.

For infusion pumps, the following surveillance steps are needed:

2.1 Search FDA Recall Database

Use the “FRN” product code to find all infusion pump recalls.

Common recall issues for infusion pumps include:

• Software miscalculations

• Over-infusion and under-infusion hazards

• Free-flow due to mechanical valve failures

• Battery shutdown failures

• Alarm or UI malfunctions.

Each recall provides:

• Failure mode

• Root cause

• Corrective action

• Potential impact on your own device design

2.2 Search MAUDE for MDR Trends

Using “FRN” in MAUDE reveals thousands of adverse event reports.

Typical MDR themes include:

• Occlusion sensor failures

• Touchscreen lockups

• Air-in-line detection failures

• Under-infusion during battery fallback

• Unrecognized pump stoppage

MDR clustering is often the earliest sign of a design or component issue.

2.3 Review Warning Letters

Search for Warning Letters involving infusion pumps or related technologies.

Common findings include:

• Inadequate software validation

• Poor CAPA investigations

• Failure to trend MDR data

• Design verification gaps.

• Weak risk management documentation

A Warning Letter issued to a competitor is often a precursor to industry-wide scrutiny.

2.4 Review 483 Observations

While not in a single FDA database, 483s can be found in:

• FDA Inspection Reports

• Public 483 repositories

• Manufacturer disclosures

Common findings for infusion pumps include:

• Incomplete alarm testing

• Inadequate flow rate accuracy verification

• Insufficient software change controls

3. Step Three: Evaluate Relevance to Your Device

After collecting external signals, the manufacturer must decide whether the risks apply to their own infusion pump.

For infusion pumps, the evaluation focuses on:

• Similar pinch valves or flow control mechanisms

• Identical sensor types

• Similar battery designs

• Shared UI or alarm logic

• Software architecture similarities

• Supplier overlap

This evaluation must be documented in the PMS and Risk Management files.

4. Step Four: Start Preventive Action — A Real Example

Here’s an integrated example.

External Signals Identified

During Predicate Device Vigilance, your team finds:

• Three recalls related to over-infusion due to worn or sticking pinch valves.

• Multiple MAUDE reports show the same issue across several manufacturers.

• A Warning Letter citing inadequate valve wear testing.

• A 483-observation describing missing verification for valve life cycle durability.

Internal Relevance

Your own infusion pump uses a similar valve technology.
Your PFMEA lists “pinch valve wear” as a potential failure mode, but only limited testing was previously conducted.

Preventive Action Initiated

Your team launches a Preventive Action that includes:

• Expanded accelerated wear testing.

• Requalification of the pinch valve supplier

• Updates to DFMEA and PFMEA

• Enhanced flow accuracy verification

• Evaluation of a potential design change

• Added software monitoring logic.

• Inclusion in the PMS Report

• Management review escalation

All triggered before any failure occurs in your own device.

This is the exact behavior FDA expects under QMSR.

5. Why This Matters for Manufacturers

Predicate Device Vigilance transforms Post-Market Surveillance from a reactive system into a strategic early-warning radar.

For infusion pumps, this approach detects:

• Systemic mechanical risks

• Software vulnerabilities

• Supplier quality issues

• Regulatory trends

• Weaknesses in competitor risk management standards

Under QMSR and ISO 13485, this is no longer optional.
It is a core requirement for compliance, product safety, and brand protection.

Conclusion: Infusion Pump Vigilance as a Model for QMSR Excellence

The infusion pump case study shows how Predicate Device Vigilance:

• Strengthens risk management.

• Drives higher design robustness.

• Supports Preventive Action

• Goes beyond traditional complaint-driven PMS

• Keeps manufacturers ahead of recalls and regulatory findings.

• Aligns directly with FDA QMSR expectations.

For companies preparing for QMSR readiness, this level of proactive surveillance is essential.
And with the right structure, it becomes a competitive advantage in MedTech.

About NoioMed

NoioMed helps MedTech manufacturers modernize PMS, CAPA, and risk management systems using structured processes and responsible AI.

We provide:

• Predicate Vigilance Playbooks and Dashboards

• CAPA360 (Comprehensive CAPA Excellence)

• Local AI for PMS Data Insight

• QMSR Transition Support