ON-Q* Pain Relief System with SELECT-A-FLOW* Variable Rate Controller SAF01Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00193494136109), received between Jun 9, 2020 and Jun 9, 2020 — classified as 3 malfunctions.

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

• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE FIRST OF THREE REPORTS. REFER TO 2026095-2020-00092 FOR THE SECOND REPORT. REFER TO 2026095-2020-00093 FOR THE THIRD REPORT. FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 18-22% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135745 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE THIRD OF THREE REPORTS. REFER TO 2026095-2020-00091 FOR THE FIRST REPORT; REFER TO 2026095-2020-00092 FOR THE SECOND REPORT. FILL VOLUME: UNKNOWN; FLOW RATE: UNKNOWN; PROCEDURE: UNKNOWN; CATHPLACE: UNKNOWN; INFUSION START TIME: UNKNOWN; INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 35% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135717 ↗
• MalfunctionJun 9, 2020Infusion or Flow Problem; Infusion or Flow Problem

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED THREE DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING THREE DIFFERENT PATIENTS. THIS IS THE SECOND OF THREE REPORTS. REFER TO 2026095-2020-00091 FOR THE FIRST REPORT. REFER TO 2026095-2020-00093 FOR THE THIRD REPORT. FILL VOLUME: UNKNOWN. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW EVENT OCCURRED; THE TOTAL INFUSION TIME WAS 18-22% FASTER THAN EXPECTED. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10135711 ↗

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