ON-Q* Elastomeric Pump 13673Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494136734), received between Feb 24, 2021 and Sep 24, 2021 — classified as 1 injury, 1 malfunction.

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 16, 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.

• MalfunctionSep 24, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 270 ML. FLOW RATE: 5ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THE PUMP "SHOULD RUN AT 5MLS/HR HOWEVER, AFTER 24 HOURS THE ELASTOMERIC BALL WAS EMPTY AFTER 24-HOURS." THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12526161 ↗
• InjuryFeb 24, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 270 ML. FLOW RATE: 5ML/HR. PROCEDURE: RIB FRACTURE. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE PUMP EMPTIED SOONER THAN EXPECTED. THE PATIENT WAS BEING TREATED FOR RIB FRACTURES AND ALSO HAD A REACTION TO THE LOCAL ANESTHETIC. PER ADDITIONAL INFORMATION RECEIVED 5 FEB 2021, A SINGLE CATHETER HAD BEEN PLACED, AND THE PUMP APPEARED TO BE EMPTY AT AROUND 36 HOURS. THE PATIENT REPORTED FEELING SICK AROUND 24 HOURS POST OPERATIVE. THE DOCTOR STATED THAT SHE FEELS THE PATIENT EXPERIENCED BUPIVACAINE TOXICITY. PER ADDITIONAL INFORMATION RECEIVED 22 FEB 2021, THE PATIENT'S CURRENT STATUS IS STABLE. THE PATIENT REPORTED THAT THEY EXPERIENCED "MENTAL STATUS CHANGE" AS A RESULT OF THE BUPIVACAINE TOXICITY. THE MEDICATION PROVIDED IN THE PUMP WAS 0.5% BUPIVACAINE. THE PATIENT WAS GIVEN A LIPID EMULSION FOR TREATMENT. THE PUMP WAS EXPECTED TO LAST TWO AND A HALF TO THREE DAYS, AND THE PUMP HAD EMPTIED LESS THAN 48 HOURS AFTER SURGERY.

  Patient problems: Unspecified Mental, Emotional or Behavioral Problem

  MAUDE report 11373754 ↗

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