MAUDE Adverse Event Report: TELEFLEX MEDICAL AF W/AS 550 X 1-14ML/HR CPNB; PUMP, INFUSION, ELASTOMERIC

Model Number	IPN924713
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	06/24/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that while in use on a patient, "the autofuser was set to 10ml per hour and the autofuser emptied completely in 24 hours.The patient had a wound vac on".Additional information received stated that "the patient was lethargic and difficult to arouse.Lipids were infused to counteract the ropivacaine and the patient seemed to respond to this.The issue was resolved by discontinuing the autofuser with ropivacaine".
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
It was reported that while in use on a patient, "the autofuser was set to 10ml per hour and the autofuser emptied completely in 24 hours.The patient had a wound vac on".Additional information received stated that "the patient was lethargic and difficult to arouse.Lipids were infused to counteract the ropivacaine and the patient seemed to respond to this.The issue was resolved by discontinuing the autofuser with ropivacaine".
Additional Manufacturer Narrative
(b)(4).The reported complaint of the pump emptying too quickly could not be confirmed based on the sample received.The customer returned one autofuser kit.Visual examination of the returned sample revealed the pump was returned completely empty with no medication.A device history record review was not performed for this investigation because a teleflex recognized batch/lot number was not provided.Based upon the information provided and the condition of the sample received, the potential cause of this complaint could not be determined.The returned sample will be returned to the supplier for further evaluation.This complaint will be reopened, and the investigation will be updated once the supplier's results become available.The reported complaint will be monitored for any developing trends.Other remarks: n/a.Corrected data: n/a.

• Brand Name: AF W/AS 550 X 1-14ML/HR CPNB
• Common Device Name: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): TELEFLEX MEDICAL; morrisville NC
• Manufacturer (Section G): TELEFLEX MEDICAL; parque industrial finsa; nuevo laredo 88275 ; MX 88275
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17342416
• Report Number: 3004365956-2023-00048
• Device Sequence Number: 15179266
• Product Code: MEB
• UDI-Device Identifier: 14026704743541
• UDI-Public: 14026704743541
• Combination Product (Y/N): N
• Initial Reporter State: NE
• Initial Reporter Country: US
• PMA/510(K) Number: K090300
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/26/2023

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 Model Number: IPN924713
• Device Catalogue Number: MVBXL-CPNB
• Device Lot Number: A211019-PS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/26/2023
• Supplement Date Received by Manufacturer: 08/14/2023
• Initial Report FDA Received Date: 07/18/2023
• Supplement Report FDA Received Date: 08/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown