MAUDE Adverse Event Report: AVANOS MEDICAL INC. ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND; ELASTOMERIC - COMBO

Model Number CB006

Device Problem Physical Resistance/Sticking (4012)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

A review of the device history record is in-progress.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 22 jun 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).

Event Description

It was reported that the bolus did not pop back up after an initial bolus dose was given to the patient.All lines were reported to be free of kinks and all clamps were undone.The device was disconnected from the patient and the patient's catheter flushed easily.The bolus button did not pop back up until two hours after the device was disconnected.Orange bolus level indicator fluctuated in position.Additional information has been requested but not yet received.

Manufacturer Narrative

The device history record for lot 20039294 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.During sample evaluation the pca button functioned as intended and there were no observed issues.During pca safety bolus test and bolus volume testing, results met specifications using the average bladder pressure.Root cause is deemed to be unknown since no defect was found.All information reasonably known as of 26 aug 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

Manufacturer Narrative

The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 19 aug 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by avanos medical inc.Represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant/reporter was unable or unwilling to provide any further patient, product, or procedural details to avanos medical inc.Avanos medical inc.Has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.This product incident is documented in the avanos medical inc.Complaint database and identified as complaint (b)(4).This information is submitted pursuant to 21cfr803, in compliance with the medical device reporting requirement and should not be considered to be an admission that an avanos medical inc.Product is defective or caused serious injury.

Event Description

Additional information received 04-aug-2021 indicated the device fill volume was 500ml, 0.2% ropivacaine.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW AND ONDEMAND
• Type of Device: ELASTOMERIC - COMBO
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 12052153
• MDR Text Key: 258062799
• Report Number: 2026095-2021-00066
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 00193494134747
• UDI-Public: 00193494134747
• Combination Product (y/n): N
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 08/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/02/2022
• Device Model Number: CB006
• Device Catalogue Number: N/A
• Device Lot Number: 20039294
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/04/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/01/2021
• Initial Date FDA Received: 06/23/2021
• Supplement Dates Manufacturer Received: 08/04/2021; 08/23/2021
• Supplement Dates FDA Received: 08/20/2021; 08/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: ROPIVACAINE, 0.2%
• Patient Age: 24 YR