Halyard 13478Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10680651134780), received between Mar 30, 2020 and Mar 30, 2020 — classified as 1 malfunction.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (1 report).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 30, 2020Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML. FLOW RATE: 5 ML/HR. PROCEDURE: ELECTIVE OPEN ABDOMINAL SURGERY. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT "ADULT PATIENT HAD UNDERGONE ELECTIVE OPEN ABDOMINAL SURGERY AND TWO ELASTOMERIC PUMPS (5ML/HR EACH OF LEVOBUPIVACAINE, FILLED TO 500 ML VOLUME) WERE USED TO PROVIDE POSTOPERATIVE ANALGESIA. ON DAY 1, ONE OF THE PUMP[S] WAS FOUND TO BE COMPLETELY EMPTY. PATIENT DID NOT EXPERIENCE ANY SIGNS OF LOCAL ANAESTHETIC TOXICITY. WOUND, DRESSINGS AND BED LINEN WAS DRY." ADDITIONAL INFORMATION RECEIVED 11-MAR-2020 INDICATED THAT THE PATIENT'S "SECOND PUMP WAS WORKING FINE." THE USER FACILITY STATED "ON-Q PUMPS ARE USED ROUTINELY IN OUR UNIT AND WE HAVE HAD NORMAL TRAINING." ADDITIONAL INFORMATION RECEIVED 18-MAR-2020 INDICATED "PATIENT WAS FOLLOWED UP TO ENSURE SAFETY."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9899278 ↗

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