MAUDE Adverse Event Report: AVANOS MEDICAL, INC. ON-Q PUMP FIXED FLOW; ELASTOMERIC LFR

Model Number	P400X4D
Medical Device Problem Code	Infusion or Flow Problem (2964)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/29/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A review of the device history record is in-progress.The product involved in the report has been returned and is being processed for evaluation.All information reasonably known as of 04 dec 2020 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 or Problem Description
Fill volume: 400 ml.Flow rate: 2 ml/hr.Procedure: bilateral mastectomy.Cathplace: unknown.Infusion start time: (b)(6) 2020.Infusion stop time: unknown.Fda medwatch / fda user facility report # mw5097398 received on 16-nov-2020, and the following information was provided: "patient underwent bilateral mastectomy on (date redacted) 2020.Two on-q pumps placed, one which malfunctioned and infused all of the drug over a shorter period of time than intended.It was a 550ml pump filled with 400ml ropivacaine 0.5%, dual catheter, flow rate 2ml/hr through each catheter.Pump removed from patient on unknown date." no patient injury or adverse effects were noted.Additional information received 17-nov-2020 indicated the procedure date and start date of the infusion was (b)(6) 2020.The pump was filled to 400ml.Additional information received 18-nov-2020 indicated the event occurred after the patient left the hospital and no further information was available in the hospital record.
Additional Manufacturer Narrative
The investigation remains in progress.All information reasonably known as of 23 dec 2020 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 device history record for lot: 30030187 was reviewed and the product was produced according to product specifications.The actual complaint product was returned for evaluation.The reported event of fast flow was confirmed.A root cause was identified.All information reasonably known as of 27 jan 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 FIXED FLOW
• Common Device Name: ELASTOMERIC LFR
• Manufacturer (Section D): AVANOS MEDICAL, INC.; 5405 windward parkway; alpharetta GA 30004
• MDR Report Key: 10967971
• Report Number: 2026095-2020-00179
• Device Sequence Number: 4282743
• Product Code: MEB
• UDI-Device Identifier: 00193494316143
• UDI-Public: 00193494316143
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: health professional,other,use
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/28/2021

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: Lay User/Patient
• Device Expiration Date: 08/18/2022
• Device Model Number: P400X4D
• Device Catalogue Number: N/A
• Device Lot Number: 30030187
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 11/16/2020
• Supplement Date Received by Manufacturer: 12/08/2020; 01/19/2021
• Initial Report FDA Received Date: 12/08/2020
• Supplement Report FDA Received Date: 12/23/2020; 01/28/2021
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ROPIVACAINE 0.5%.
• Patient Age: 53 YR
• Patient Weight: 110