ON-Q* Pain Relief System with NRFit™ Connector 37612Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494376123), received between Jan 7, 2022 and Apr 21, 2022 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (2 reports).

3 other recalls cover devices cleared under the same FDA submission (K063530); they may or may not involve this specific model.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP EMPTIED IN JUST 1-DAY. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14167913 ↗
• MalfunctionJan 7, 2022Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 550 ML. FLOW RATE: 8ML/HR. PROCEDURE: LEFT KNEE REPLACEMENT. CATHPLACE: LEFT KNEE AREA. DATE OF PROCEDURE: (B)(6) 2021. IT WAS REPORTED, "THE INFUSION WAS SUPPOSED TO BE FOR 72 HOURS, BUT FINISHED ON THE 16TH AT 11:00 PM." THERE WAS NO REPORTED INJURY AND THE PATIENT NOTED THERE WERE NO SYMPTOMS OR LEAKING/WETNESS AT SITE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13193093 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K063530. One submission often covers many models, so check the product and lot details in each record.

• Z-2860-2011 · Apr 15, 2011 · Terminated
  I-Flow ON-Q with Select-A-Flow Pumps, Intended for continuous and/or intermittent delivery of medication to and around surgical wound sites and/or close proximity to nerves for p
• Z-2133-2008 · Feb 14, 2008 · Terminated
  On-Q C-bloc 400 ml, 1-7 ml/hr Select-A-Flow + 5 ml/60 min ONDEMAND, REF CB005 indicated for continuous and/or intermittent delivery of medication (such as local anesthetics or narc
• Z-1869-2008 · Feb 12, 2008 · Terminated
  ON-Q PainBuster Infusion Pump (270 ml, 5 ml/hr), REF PS6504, Part No. 5001260. The pump is indicated for continuous and/or intermittent delivery of medication (such as local anest