ON-Q* C-bloc Intl Pain Relief System with SELECT-A-FLOW* and ONDEMAND* 13483Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00193494134839), received between Sep 3, 2021 and Jan 3, 2024 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (3 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 3, 2024Improper Flow or Infusion; Improper Flow or Infusion

  IT WAS REPORTED, PRODUCT HAD FAST OVER-INFUSION. ¿THE PUMP WAS CONNECTED TO AN ISK AND RAN THROUGH TOO QUICKLY PATIENT HAD A SEIZURE. THE BOLUS GENERATOR WAS PRESSED, AND THE PATIENT PRESSED AND HELD (NOT RELEASED TO REFILL THE BOLUS FILLING OF THE BOLUS GENERATOR).¿ NO MEDICAL INTERVENTIONS WERE REPORTED.

  Patient problems: Convulsion/Seizure

  MAUDE report 18440232 ↗
• MalfunctionDec 16, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED THE DEVICE WAS TO INFUSE IN 4-DAYS, HOWEVER THE DEVICE INFUSED IN 24-HOURS. THERE WAS NO REPORTED PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13021331 ↗
• MalfunctionDec 15, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  IT WAS REPORTED BY THE ANESTHESIOLOGIST THAT THE INFUSION WAS SUPPOSED TO BE OVER FOUR DAYS BUT HAD COMPLETED IN 24 HOURS. THE PATIENT REPORTED THAT HE DID NOT USE THE BOLUS. THERE WAS NO INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13010081 ↗
• MalfunctionSep 3, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  ADDITIONAL INFORMATION RECEIVED 06-SEP-2021 INDICATED THAT IT "SEEMS THAT THE BOLUS ON-Q PUMP WAS NOT USED ACCORDINGLY."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12422807 ↗

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