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

Model Number	CB004
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/11/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Fill volume: 100 ml, flow rate: 2 ml/hr, procedure: total knee replacement, cathplace: surgical wound site, infusion start time: (b)(6) 2021 at 1230, infusion stop time: (b)(6) 2021 at 2130.It was reported that the pump emptied overnight.It was only supposed to run at 2ml/hr and at the point the over-infusion was noted, only 40ml should have been infused, however, 90ml had infused.The pump was filled with 100ml of a local anesthetic, which is less than labeled volume.Additional information received 19-apr-2021 indicated the "scrub nurse arrived in theatre and package of on q pump opened and discarded and not seen by nurse who filled the pump.Scrub and scout nurse unfamiliar with the pump.The pain pump usually used by this surgeon was unavailable.The [anesthetist] was asked if the pump could be filled with 100ml 0.75% naropin and the team were given the go ahead.The pain pump was set to 2 ml per hour delivery and attached to the patient.The pain pump was found on the ward empty on the night duty.Increased surveillance of the patient.Patient developed no sign of local anesthetic toxicity." patient's current status was listed as "ok, no adverse events reported.Nil adverse reaction reported." additional information has been requested but not yet received.
Additional Manufacturer Narrative
The device history record for lot 30042554 was reviewed and the product was produced according to product specifications.The sample is reported to be available, but has not yet been received by the manufacturer.All information reasonably known as of 05 may 2021 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.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).
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The investigation remains in progress.All information reasonably known as of 01 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) 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.
Additional Manufacturer Narrative
The actual complaint product was returned for evaluation.The pump's distal end infused and passed the specification on selectable flow rates 4ml/hr and 8ml/hr; however, in the flow rate 2ml/hr, multiple unknown substances were noted to be built-up in the tubing.The unknown substances inside the tubing appeared to potentially be crystallized medication.The root cause was determined to be use error.According to information received, the product was not used in accordance with the instructions for use.The customer indicated the pump was filled with 100ml of local anesthetic.Per the ifu, filling the pump less than the labeled volume (400ml) results in faster flow rate.All information reasonably known as of 17 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).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.

• Brand Name: ON-Q PUMP WITH SELECT-A-FLOW
• Common Device Name: ELASTOMERIC - SAF
• Manufacturer (Section D): AVANOS MEDICAL INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 11787596
• Report Number: 2026095-2021-00055
• Device Sequence Number: 16947783
• Product Code: MEB
• UDI-Device Identifier: 00193494134723
• UDI-Public: 00193494134723
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K063530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other,use
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/18/2021

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
• Operator of Device: Health Professional
• Device Expiration Date: 09/09/2022
• Device Model Number: CB004
• Device Catalogue Number: N/A
• Device Lot Number: 30042554
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/10/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 04/14/2021
• Supplement Date Received by Manufacturer: 05/10/2021; 06/03/2021
• Initial Report FDA Received Date: 05/06/2021
• Supplement Report FDA Received Date: 06/03/2021; 06/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 0.75% NAROPIN