ON-Q* C-bloc Pain Relief System CB002Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00193494134693), received between Feb 22, 2023 and Aug 29, 2023 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (4 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2023

  PATIENT REPORTED SEVERE PAIN ALL NIGHT AND DID NOT THINK ON-Q PUMP WAS WORKING. PATIENT DID NOT SEE ANY KINKS IN THE TUBING AND THE TUBING IS NOT CLAMPED. HAD PATIENT DISCONNECT THE TUBING FROM THE CATHETER WITH HELP FROM THE FAMILY AND THEY DID NOT SEE ANYTHING DRIPPING FROM THE END OF THE ON-Q TUBING. ON-Q PUMP HAS NOT DECREASED IN SIZE SINCE CONNECTION YESTERDAY. PATIENT WAS INSTRUCTED TO REMOVE THE NERVE CATHETER AND REPORT HER LACK OF PAIN CONTROL TO HER SURGICAL TEAM.

  Patient problems: Inadequate Pain Relief

  MAUDE report 17641207 ↗
• InjuryMar 23, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: (B)(6) 2023. FDA MEDWATCH / FDA USER FACILITY REPORT MW REPORT (B)(4) REPORTED, THE ONQ PUMP INFUSION COMPLETED ABOUT 24 HOURS EARLIER THAN EXPECTED. THE PATIENT NOTED THE PUMP [WAS] COMPLETE AT 1900; THE PUMP SHOULD HAVE FINISHED AT 2200 THE NEXT DAY. THE PATIENT REPORTED A RETURN OF MOTOR AND SENSATION AFTER THE INFUSION WAS NOTED TO BE COMPLETE; THERE WERE NO REPORTED SIGNS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Numbness

  MAUDE report 16599594 ↗
• MalfunctionMar 2, 2023Excess Flow or Over-Infusion

  ONQ PUMP INFUSION COMPLETED ABOUT 24 HOURS EARLIER THAN EXPECTED. PATIENT NOTED PUMP COMPLETE AT 1900. PUMP SHOULD HAVE FINISHED AT 2200 THE NEXT DAY. PATIENT REPORTED RETURN OF MOTOR AND SENSATION AFTER INFUSION NOTED TO BE COMPLETE. NO SIGNS OF LAST NOTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16466565 ↗
• MalfunctionFeb 22, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE SECOND OF TWO REPORTS. REFER TO 2026095-2023-00015 FOR THE FIRST EVENT. FILL VOLUME: 550 ML . FLOW RATE: 10 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS A FAST FLOW INCIDENT WITH THE PUMP. THERE WAS NO INJURY REPORTED. THE CUSTOMER ALSO REPORTED THAT IT IS SUSPECTED BUT NOT CONFIRMED THAT THE PUMP "WAS PROBABLY UNDER BLANKETS/WARMED DURING INFUSION, WHICH MAY HAVE CAUSED THE FAST FLOW". ADDITIONAL INFORMATION WAS RECEIVED ON 01-FEB-2023 VIA MEDWATCH/ FDA USER FACILITY REPORT MW REPORT (B)(4): "20307- INFUSED TOO RAPIDLY- PATIENT SENT HOME WITH FIXED RATE ON Q PUMP ON [DATE REDACTED] TO RUN AT 10 ML/HOUR, 550 ML PUMP. SHOULD HAVE BEEN EMPTY BY 1730 ON [DATE REDACTED]. PATIENT REPORTED THAT IT WAS EMPTY BY 10 A.M. ON [DATE REDACTED]. HE DISPOSED OF PUMP AT THAT TIME".

  Patient problems: Insufficient Information

  MAUDE report 16422391 ↗
• MalfunctionFeb 22, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING TWO DIFFERENT EVENTS. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2023-00016 FOR THE SECOND EVENT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED THERE WAS A FAST FLOW INCIDENT WITH THE PUMP. THERE WAS NO INJURY REPORTED. THE CUSTOMER ALSO REPORTED THAT IT IS SUSPECTED BUT NOT CONFIRMED THAT THE PUMP "WAS PROBABLY UNDER BLANKETS/WARMED DURING INFUSION, WHICH MAY HAVE CAUSED THE FAST FLOW." ADDITIONAL INFORMATION WAS RECEIVED ON 01-FEB-2023 VIA MEDWATCH/ FDA USER FACILITY REPORT MW REPORT (B)(4): DESCRIBE THE EVENT OR PROBLEM: 19600- INFUSED TOO RAPIDLY- PATIENT NOTED THAT ON Q PUMPS INFUSED 8 HOURS PRIOR TO EXPECTED TIME THAT THEY SHOULD HAVE BEEN EMPTY. THEY WERE THROWN AWAY AND NOT ABLE TO SEND BACK TO CLINIC.

  Patient problems: Insufficient Information

  MAUDE report 16421706 ↗

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