ON-Q* C-bloc with SELECT-A-FLOW* and ONDEMAND* 13474Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 00193494134747), received between Jun 19, 2020 and Apr 11, 2025 — classified as 1 injury, 19 malfunctions.

The most frequently reported specific device problem is “Excess Flow or Over-Infusion” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 11, 2025Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE FIRST OF TWO REPORTS. REFER TO 2026095-2025-00008 FOR THE SECOND REPORT. FILL VOLUME: 545 ML FLOW RATE: UNKNOWN PROCEDURE: UNKNOWN CATH PLACE: UNKNOWN INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, ¿A PATIENT WAS CONTINUING TO HOLD THE BOLUS BUTTON DOWN AND WHEN INSTRUCTED TO RELEASE IT STAYED IN THE LOCKED POSITION. THE ACCOUNT HAS SOME CONCERNS THAT THE BOLUS BUTTON CAN BE HELD AND CONTINUE TO DELIVER A HIGHER/ LOWER VOLUME (NOT A TRUE LOCKOUT) THAN THE 5ML/ 30 MIN. CONFIRMED WITH THE ACCOUNT THAT THE BOLUS IS READY EVERY 30 MIN WHEN THE ORANGE LINE INDICATOR IS AT THE TOP OF THE SIDE WINDOW." PER NOTE RECEIVED WITH SAMPLE RETURN ON 26MAR2025, ¿ON DEMAND CONTROL NOT LOCKING PATIENT OUT. ABLE TO GIVE DOES, THEN GIVE AGAIN. I PUSHED IT WHEN NOT CONNECTED TO PATIENT AND IT BLOUSED AROUND 3-5 ML 10 MINUTES AFTER LAST DOES. PATIENT GOT APPROXIMATELY 10ML BOLUS WITHIN 45 MINUTES.¿

  Patient problems: Insufficient Information

  MAUDE report 21830597 ↗
• MalfunctionApr 11, 2025Improper Flow or Infusion; Improper Flow or Infusion

  AVANOS MEDICAL INC. RECEIVED A SINGLE REPORT THAT REFERENCED TWO DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING ONE PATIENT. THIS IS THE SECOND OF TWO REPORTS. FILL VOLUME: 545 ML, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN, INFUSION START TIME: UNKNOWN, INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, ¿A PATIENT WAS CONTINUING TO HOLD THE BOLUS BUTTON DOWN AND WHEN INSTRUCTED TO RELEASE IT STAYED IN THE LOCKED POSITION. THE ACCOUNT HAS SOME CONCERNS THAT THE BOLUS BUTTON CAN BE HELD AND CONTINUE TO DELIVER A HIGHER/ LOWER VOLUME (NOT A TRUE LOCKOUT) THAN THE 5ML/ 30 MIN. CONFIRMED WITH THE ACCOUNT THAT THE BOLUS IS READY EVERY 30 MIN WHEN THE ORANGE LINE INDICATOR IS AT THE TOP OF THE SIDE WINDOW.¿ PER NOTE RECEIVED WITH SAMPLE RETURN ON 26MAR2025, ¿ON DEMAND CONTROL NOT LOCKING PATIENT OUT. ABLE TO GIVE DOES, THEN GIVE AGAIN. I PUSHED IT WHEN NOT CONNECTED TO PATIENT AND IT BLOUSED AROUND 3-5 ML 10 MINUTES AFTER LAST DOES. PATIENT GOT APPROXIMATELY 10ML BOLUS WITHIN 45 MINUTES.¿

  Patient problems: Insufficient Information

  MAUDE report 21830455 ↗
• MalfunctionAug 22, 2024Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN, FLOW RATE: 6ML/HR. PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS REPORTED, THE PUMP WAS COMPLETELY EMPTY AFTER ONE DAY. NO CLINICAL'S SIGNS OF LOCAL ANESTHETIC TOXICITY. ON (B)(6) 2024 [THE PHYSICIAN] SPOKE TO A PATIENT AT HOME WITH AN ONQ IN PLACE: [THE PATIENT] SAID THE PUMP HAD BEEN REPLACED THE DAY PRIOR BEFORE [THE PATIENT] WAS DISCHARGED, AND THAT ON THE (B)(6) IT WAS COMPLETELY EMPTY. [THE PATIENT] SAID THE INSIDE OF THE BLACK BAG WAS DRY, AND [THE PATIENT] CLOTHING/BEDDING WAS ALSO DRY, LEADING [THE PHYSICIAN] TO THINK IT WAS NOT AN EXTERNAL LEAK. [THE PATIENT] ... CLICKED THE BUTTON ABOUT [THREE TIMES] TOTAL BETWEEN LEAVING THE HOSPITAL AND [THE PHYSICIAN] CALL ABOUT 24 HOURS LATER. [THE PHYSICIAN] ASKED [THE PATIENT] TO RECHECK THE RATE AND [THE PATIENT'S SPOUSE] NOTED THE RATE WAS SET AT 6ML/HR. [THE CLINICAL TEAM] FOLLOWED UP CLOSELY AND [THE PATIENT] HAS DONE WELL CLINICALLY WITHOUT ANY CONCERN FOR LOCAL ANESTHETIC TOXICITY, BUT IT IS STILL CONCERNING IF THE PUMP INDEED RAN THAT FAST." THE WAS NO REPORTS OF INJURY OTHER THAN DELAY IN TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20035213 ↗
• MalfunctionJan 5, 2024Failure to Reset; Improper Flow or Infusion; Failure to Eject; Failure to Reset; Improper Flow or Infusion; Failure to Eject

  FILL VOLUME: 545 ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: DECEMBER 15, 2023. IT WAS REPORTED, THE BUTTON GOT STUCK DOWN AFTER THE PATIENT PRESSED IT. IT RESULTED IN THE PATIENT BEING ADMITTED TO THE EMERGENCY DEPARTMENT BECAUSE THE DRUG CONTINUED TO INFUSE, AND THE PATIENT'S ARM WENT NUMB. PATIENT¿S HUSBAND CUT THE LINE TO END THE INFUSION. NO MEDICAL INTERVENTIONS REPORTED. PER ADDITIONAL INFORMATION RECEIVED 19DEC2023, PATIENT PUSHED THE BUTTON AND IT REMAINED STUCK IN PUSH [DOWN] POSITION. A FEW MINUTES LATER, HER ARM WAS GETTING PROGRESSIVELY NUMB AND WEAK. PATIENT'S HUSBAND THEN USED SCISSORS TO CUT THE TUBING OF THE PUMP. THE CATHETER WAS REMOVED IN THE EMERGENCY DEPARTMENT AROUND 2AM.

  Patient problems: Alteration in Body Temperature; Inadequate Pain Relief; Muscle Weakness/Atrophy; Numbness; Tachycardia

  MAUDE report 18455538 ↗
• MalfunctionNov 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FOURTH OF FOUR REPORTS. REFER TO 2026095-2023-00104 FOR THE FIRST EVENT. REFER TO 2026095-2023-00105 FOR THE SECOND EVENT. REFER TO 2026095-2023-00106 FOR THE THIRD EVENT. FILL VOLUME: 400ML. FLOW RATE: 4 ML/HR. PROCEDURE: UNKNOWN . CATH PLACED: ADDUCTOR CANAL, SCIATIC POPLITEAL. INFUSION START TIME: (B)(6) 2023 AT 19:59. INFUSION STOP TIME: (B)(6) 2023 AT 11:04. IT WAS REPORTED THERE WAS A "FAST FLOW INCIDENT" INVOLVING AN ON-Q PUMP. A TRAUMA PATIENT ADMITTED TO OPERATING ROOM THE DEVICE WAS CONNECTED TO THE PATIENT, RED TAB WAS NOT REMOVED FROM PATIENT-CONTROLLED ANALGESIA (PCA) PUMP. A TOTAL OF 400ML WAS DELIVERED IN LESS THAN 15-HOURS. THE PATIENT STILL REPORTED PAIN. THERE WAS NO REPORTED INJURY. PATIENT DISCHARGED, NO ADVERSE OUTCOME REPORTED.

  Patient problems: Pain

  MAUDE report 18144784 ↗
• MalfunctionNov 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE THIRD OF FOUR REPORTS. REFER TO 2026095-2023-00104 FOR THE FIRST EVENT. REFER TO 2026095-2023-00105 FOR THE SECOND EVENT. REFER TO 2026095-2023-00107 FOR THE FOURTH EVENT. FILL VOLUME: 400ML. FLOW RATE: 4 ML/HR. PROCEDURE: UNKNOWN. CATH PLACED: ADDUCTOR CANAL, SCIATIC POPLITEAL. INFUSION START TIME: (B)(6) 2023 AT 19:59. INFUSION STOP TIME: 19-OCT-2023 AT 11:04. IT WAS REPORTED THERE WAS A "FAST FLOW INCIDENT" INVOLVING AN ON-Q PUMP. A TRAUMA PATIENT ADMITTED TO OPERATING ROOM THE DEVICE WAS CONNECTED TO THE PATIENT, RED TAB WAS NOT REMOVED FROM PATIENT-CONTROLLED ANALGESIA (PCA) PUMP. A TOTAL OF 400ML WAS DELIVERED IN LESS THAN 15-HOURS. THE PATIENT STILL REPORTED PAIN. THERE WAS NO REPORTED INJURY. PATIENT DISCHARGED, NO ADVERSE OUTCOME REPORTED.

  Patient problems: Pain

  MAUDE report 18144782 ↗
• MalfunctionNov 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE FIRST OF FOUR REPORTS. REFER TO 2026095-2023-00105 FOR THE SECOND EVENT. REFER TO 2026095-2023-00106 FOR THE THIRD EVENT. REFER TO 2026095-2023-00107 FOR THE FOURTH EVENT. FILL VOLUME: 500ML. FLOW RATE: 4 ML/HR. PROCEDURE: UNKNOWN. CATH PLACED: ADDUCTOR CANAL, SCIATIC POPLITEAL. INFUSION START TIME: 17-OCT-2023 AT 17:27. INFUSION STOP TIME: 18-OCT-2023 AT 19:59. . IT WAS REPORTED THERE WAS A "FAST FLOW INCIDENT" INVOLVING AN ON-Q PUMP. A TRAUMA PATIENT ADMITTED TO OPERATING ROOM THE DEVICE WAS CONNECTED TO THE PATIENT, RED TAB WAS NOT REMOVED FROM PATIENT-CONTROLLED ANALGESIA (PCA) PUMP. A TOTAL OF 500ML WAS DELIVERED IN LESS THAN 26-HOURS. THE PATIENT STILL REPORTED PAIN. THERE WAS NO REPORTED INJURY. PATIENT DISCHARGED, NO ADVERSE OUTCOME REPORTED.

  Patient problems: Pain

  MAUDE report 18144778 ↗
• MalfunctionNov 15, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  AVANOS MEDICAL RECEIVED A SINGLE REPORT THAT REFERENCED FOUR DIFFERENT INCIDENCES, WHICH WERE ASSOCIATED WITH SEPARATE UNITS, INVOLVING FOUR DIFFERENT EVENTS. THIS IS THE SECOND OF FOUR REPORTS. REFER TO 2026095-2023-00104 FOR THE FIRST EVENT. REFER TO 2026095-2023-00106 FOR THE THIRD EVENT. REFER TO 2026095-2023-00107 FOR THE FOURTH EVENT. FILL VOLUME: 500ML. FLOW RATE: 4 ML/HR. PROCEDURE: UNKNOWN . CATH PLACED: ADDUCTOR CANAL, SCIATIC POPLITEAL. INFUSION START TIME: (B)(6) 2023 AT 17:27. INFUSION STOP TIME: (B)(6) 2023 AT 19:59. IT WAS REPORTED THERE WAS A "FAST FLOW INCIDENT" INVOLVING AN ON-Q PUMP. A TRAUMA PATIENT ADMITTED TO OPERATING ROOM THE DEVICE WAS CONNECTED TO THE PATIENT, RED TAB WAS NOT REMOVED FROM PATIENT-CONTROLLED ANALGESIA (PCA) PUMP. A TOTAL OF 500ML WAS DELIVERED IN LESS THAN 26-HOURS. THE PATIENT STILL REPORTED PAIN. THERE WAS NO REPORTED INJURY. PATIENT DISCHARGED, NO ADVERSE OUTCOME REPORTED.

  Patient problems: Pain

  MAUDE report 18144777 ↗
• MalfunctionMay 25, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: UNKNOWN ML . FLOW RATE: 6 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED A FAST FLOW OCCURRED; THE DEVICE FINISHED WITHIN 24-HOURS. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17006055 ↗
• MalfunctionApr 21, 2023Physical Resistance/Sticking; Physical Resistance/Sticking

  FILL VOLUME: UNKNOWN, FLOW RATE: UNKNOWN, PROCEDURE: UNKNOWN, CATHPLACE: UNKNOWN. IT WAS INITIALLY REPORTED "BOLUS BUTTON STAYING DECOMPRESSED. THE BUTTON WAS STUCK DOWN, AND COULD NOT INITIALLY GET IT BACK UP. GOING AS FAR AS SMACKING IT A FEW TIMES WITH A STAPLER. THE BUTTON WAS DOWN, THE CHAMBER WAS INDICATING IT WAS FULL, SO THE USER TRIED LETTING THE CHAMBER RUN OUT ALLOWING THE BUTTON TO POP BACK UP. THE BUTTON ONLY POPS BACK UP WHEN THE CHAMBER EMPTIES, BUT GIVEN THE TIME IT TOOK TO CALL A NURSE AND GET THE PAIN TEAM OVER (LIKELY HOURS). THERE WAS NO REPORTED INJURY.

  Patient problems: Insufficient Information

  MAUDE report 16784615 ↗
• MalfunctionMar 28, 2023Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500 ML. FLOW RATE: 4 ML/HR. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. IT WAS REPORTED "THE PUMP HAD COMPLETELY INFUSED AFTER 24-HOURS . THEATRE STAFF DIDN¿T WANT THE PATIENT TO BE ABLE TO USE THE BOLUS FEATURE, SO NEVER REMOVED THE RED TAB. THE [COMPANY REPRESENTATIVE] EXPLAINED THIS IS WHY THE PUMP HAS INFUSED MUCH QUICKER, DESPITE THE FLOW RATE BEING SET AT 4ML/HR. THE PUMP WAS FILLED WITH 500ML 0.2% ROPIVACAINE." ADDITIONAL INFORMATION RECEIVED 14-MAR-2023 REPORTED, THERE [WAS] NO UNTOWARD EFFECT FROM THE INCIDENT OR UNPLANNED FURTHER TREATMENT REQUIRED. THERE WAS NO REPORTED INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16628217 ↗
• MalfunctionAug 4, 2022Improper Flow or Infusion; Improper Flow or Infusion

  FILL VOLUME: UNKNOWN ML. FLOW RATE: UNKNOWN. PROCEDURE: UNKNOWN. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED, THE ON-Q PUMP HAD A FAST FLOW AND WAS COMPLETELY OUT OF LOCAL ANESTHETIC WITHIN 24 HOURS OF BEING ATTACHED TO THE PATIENT. THERE WAS NO REPORTED MEDICAL INTERVENTION OR PATIENT INJURY.

  Patient problems: Insufficient Information

  MAUDE report 15167825 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS EXPERIENCING A VESICULAR BLISTERING RASH POST REMOVAL OF ONQ PUMP AT THE INSERTION SITE. THE PATIENT REPORTED THAT THE RASH HAD MOVED OUT OF THE IMMEDIATE SURGICAL SITE AREA AND SPREAD TO THEIR GROIN AND LOWER; THEY WERE TAKING BENADRYL,PER THE DOCTORS ORDERS AND THEY HAD A FOLLOW UP APPOINTMENT WITH THE DOCTOR THE FOLLOWING DAY. THE PATIENT¿S CURRENT CONDITION IS UNKNOWN.

  Patient problems: Rash

  MAUDE report 14476344 ↗
• MalfunctionAug 3, 2021Excess 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: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW OCCURRED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: Insufficient Information

  MAUDE report 12266853 ↗
• MalfunctionAug 3, 2021Excess Flow or Over-Infusion; Excess Flow or Over-Infusion

  FILL VOLUME: 500ML. FLOW RATE: 10ML/HR. PROCEDURE: UNKNOWN . CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT A FAST FLOW OCCURRED. THERE WAS NO HARM TO THE PATIENT. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12266846 ↗
• MalfunctionJun 28, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  FILL VOLUME: 550ML. FLOW RATE: 8ML BASAL, 5ML BOLUS. PROCEDURE: TOTAL KNEE REPLACEMENT, ADDUCTOR CANAL NERVE BLOCK. CATHPLACE: MID-THIGH. INFUSION START TIME: (B)(6) 2021 APPROXIMATELY MID DAY. INFUSION STOP TIME: (B)(6) 2021. IT WAS REPORTED THAT THE BOLUS BUTTON QUIT FUNCTIONING. THE BOLUS BUTTON WAS NOT ENGAGING DOWN AND RESERVOIR WAS NOT REFILLING ON THE PAIN PUMP ATTACHED TO THE PATIENT. THE PATIENT WAS 24 HOURS POST CONNECTION WITH THE PUMP AND IT VISUALLY APPEARED TO HAVE BEEN DEFLATING, HOWEVER, AS THE NURSING STAFF DESCRIBED THE BOLUS BUTTON WOULD NOT ENGAGE DOWN AND THE ORANGE INDICATOR SHOWED THE 5ML BOLUS RESERVOIR WAS EMPTY. THE NURSE DISCONNECTED THE PUMP AND THE LOCAL ANESTHETIC WAS DRIPPING OUT THE END WHICH SUGGESTED THAT THE PATIENT WAS STILL RECEIVING THE BACKGROUND BASAL RATE (WHICH WAS SET AT 8ML/HR). SALES REP WAS PRESENT WHEN THE PUMP WAS INITIALLY CONNECTED TO THE PATIENT IN THE RECOVERY ROOM AND HAD WITNESSED THAT AT LEAST FOR THE FIRST FEW ADMINISTRATIONS THAT THE BOLUS BUTTON WAS WORKING CORRECTLY AT ONE TIME. NO PATIENT HARM WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12080692 ↗
• MalfunctionJun 23, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  ADDITIONAL INFORMATION RECEIVED 04-AUG-2021 INDICATED THE DEVICE FILL VOLUME WAS 500ML, 0.2% ROPIVACAINE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12052153 ↗
• MalfunctionJun 4, 2021Improper or Incorrect Procedure or Method; Infusion or Flow Problem; Improper or Incorrect Procedure or Method; Infusion or Flow Problem

  FILL VOLUME: 500 ML, FLOW RATE: UNKNOWN, PROCEDURE: KNEE REPLACEMENT, CATHPLACE: ADDUCTOR CANAL BLOCK, INFUSION START TIME: (B)(6) 2021, TIME NOT PROVIDED. INFUSION STOP TIME:(B)(6) 2021, 0800. IT WAS REPORTED THAT THE DEVICE DELIVERED LOCAL ANESTHETIC AT A FAST FLOW RATE. THE PUMP WAS SET UP FOR A CONTINUOUS, SURGEON-PLACED ADDUCTOR CANAL BLOCK AND WHEN CHECKED ON THE MORNING OF (B)(6) 2021 WAS FOUND TO BE ALMOST DEPLETED. THE PUMP WAS FILLED TO 500ML, HOWEVER THE RED TAB WAS NOT REMOVED. IT WAS IDENTIFIED THAT A NEW NURSE SET UP THE PUMP THE DAY PRIOR. THE PUMP WAS CLAMPED WHEN THE FAST FLOW WAS IDENTIFIED. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 13-MAY-2021 INDICATED THE SITE HAS BEEN USING ON-Q SINCE 2013, AND THE ON DEMAND MODEL SINCE 2018.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11938245 ↗
• MalfunctionApr 7, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  FILL VOLUME: 550 ML. FLOW RATE: 8 ML/HR. PROCEDURE: TOTAL KNEE REPLACEMENT. CATHPLACE: UNKNOWN. INFUSION START TIME: UNKNOWN. INFUSION STOP TIME: UNKNOWN. IT WAS REPORTED THAT THE BOLUS BUTTON ON THE PUMP "DID NOT POP BACK UP AFTER BEING PRESSED TO ADMINISTER A 5ML BOLUS. THE RED FILL LINE INDICATOR HAS NOT MOVED FROM THE BOTTOM TO THE TOP OF THE BOLUS." THE ANESTHESIOLOGIST DECIDED TO CLAMP THE PUMP AND REMOVE IT FROM THE PATIENT. NO PATIENT HARM WAS REPORTED. ADDITIONAL INFORMATION RECEIVED 30-MAR-2021 INDICATED THE PRIMING TAB WAS REMOVED PRIOR TO PATIENT USE AND THE PRIMING KEY DID NOT BREAK UPON REMOVAL. THIS INCIDENT WAS THE FIRST TIME THE BOLUS BUTTON WAS DEPRESSED. FILLING PROCEDURE FOR THIS SPECIFIC OCCASION IS UNKNOWN. THE ANESTHESIOLOGIST WAS ATTACHING THE PUMP TO AN ALTERNATIVE BRANDED NERVE CATHETER AND A FILTER MAY HAVE BEEN ATTACHED TO THE CATHETER BEFORE THE CATHETER WAS ATTACHED TO THE PUMP. PUMP WAS FILLED WITH 0.2% ROPIVACAINE. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT NOT YET RECEIVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11628873 ↗
• MalfunctionJun 19, 2020Excess Flow or Over-Infusion; Use of Device Problem; Excess Flow or Over-Infusion; Use of Device Problem

  PER ADDITIONAL INFORMATION REC'D 26 JUN 2020: PROCEDURE: RIGHT KNEE ARTHROSCOPY WITH ANTERIOR CRUCIATE LIGAMENT RECONSTRUCTION WITH PARTIAL MENISCUS REPAIR; INFUSION START TIME: APPROX 14:30; INFUSION STOP TIME: PT REPORTED OUT AT 12:00 THE FOLLOWING DAY- LESS THAN 24HOURS. PER ADDITIONAL INFORMATION RECEIVED 30 JUN 2020, THE PUMP WAS A NEW ONE TO THE CUSTOMER AND THEY HAD NOT RECEIVED IN-SERVICE TRAINING ON IT. THE CUSTOMER HAS SINCE RECEIVED TRAINING ON HOW TO REMOVE THE RED TAB.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10174256 ↗

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