AVANOS CB004-PFRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00193494001339), received between Nov 21, 2023 and May 10, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 10, 2024

  BUPIVACAINE ONQ PUMP CB004 SET UP AND INITIATED AT APPROXIMATELY 14:00 TO INFUSE AT 10ML/HR FOR 55 HOURS AND END AT 23:00 2 DAYS LATER. UPON SPEAKING TO PATIENT, THE PUMP EMPTIED EARLY IN THE MORNING ESTIMATED AT 01:00. NO SIDE EFFECTS OR SYMPTOMS OF LOCAL ANESTHETIC SYSTEMIC TOXICITY (LAST). NURSE MANAGER INFORMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19285582 ↗
• MalfunctionNov 21, 2023Break; Break

  IT WAS REPORTED THE "CATHETER BROKE WHEN SHE GOT OUT OF BED... INSTRUCTED TO REMOVE CATHETER REMAINING IN THIGH." THERE WAS NO REPORTED INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18183720 ↗

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