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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; PUMP, INFUSION, ELASTOMERIC
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AVANOS MEDICAL, INC. ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW; PUMP, INFUSION, ELASTOMERIC Back to Search Results
Model Number 13472
Device Problem Pumping Problem (3016)
Patient Problems Nausea (1970); Balance Problems (4401)
Event Date 12/10/2022
Event Type  malfunction  
Event Description
Event1: on-q pump ran out in 30 hours instead of expected 55 hours.Pump has been returned and is currently under evaluation.Dial was set at appropriate prescribed rate of 10 ml/hr.Clamp was open and all appeared to be visibly intact, as would be expected.Patient reported nausea and balance issues, which is thought to be likely a side effect of the faster infusion.Event2: patient's on-q pump was still half full when it was time to be removed.Rate dial set at programmed rate.Infusion clamp was open.Patient instructed to bring catheter and on-q pump with him for return visit.Event3: i have a patient that went home yesterday with an on-q and the pump is not infusing.The pump has been connected for 24 hours and the patient says it has not decreased in size at all.Rate dial verified.Patient instructed to bring pump back for return visit.
 
Event Description
Event1: on-q pump ran out in 30 hours instead of expected 55 hours.Pump has been returned and is currently under evaluation.Dial was set at appropriate prescribed rate of 10 ml/hr.Clamp was open and all appeared to be visibly intact, as would be expected.Patient reported nausea and balance issues, which is thought to be likely a side effect of the faster infusion.Event2: patient's on-q pump was still half full when it was time to be removed.Rate dial set at programmed rate.Infusion clamp was open.Patient instructed to bring catheter and on-q pump with him for return visit.Event3: i have a patient that went home yesterday with an on-q and the pump is not infusing.The pump has been connected for 24 hours and the patient says it has not decreased in size at all.Rate dial verified.Patient instructed to bring pump back for return visit.
 
Event Description
Event1: on-q pump ran out in 30 hours instead of expected 55 hours.Pump has been returned and is currently under evaluation.Dial was set at appropriate prescribed rate of 10 ml/hr.Clamp was open and all appeared to be visibly intact, as would be expected.Patient reported nausea and balance issues, which is thought to be likely a side effect of the faster infusion.Event2: patient's on-q pump was still half full when it was time to be removed.Rate dial set at programmed rate.Infusion clamp was open.Patient instructed to bring catheter and on-q pump with him for return visit.Event3: i have a patient that went home yesterday with an on-q and the pump is not infusing.The pump has been connected for 24 hours and the patient says it has not decreased in size at all.Rate dial verified.Patient instructed to bring pump back for return visit.
 
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Brand Name
ON-Q PAIN RELIEF SYSTEM WITH SELECT-A-FLOW
Type of Device
PUMP, INFUSION, ELASTOMERIC
Manufacturer (Section D)
AVANOS MEDICAL, INC.
5405 windward parkway
alpharetta GA 30004
MDR Report Key16111323
MDR Text Key306798493
Report Number16111323
Device Sequence Number1
Product Code MEB
UDI-Device Identifier00193494134723
UDI-Public00193494134723
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 01/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/06/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Model Number13472
Device Catalogue NumberCB004
Device Lot Number30179495
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA01/03/2023
Event Location Home
Date Report to Manufacturer01/06/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
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