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	Lethargy (2560)
Date of Event	06/22/2023
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 8ml per hour and the autofuser emptied completely in 24 hours.The patient had a wound vac on".No patient harm or injury.The patient status is reported as "fine".Additional information received stated that the "patient was somnolent after 24 hours of infusion (500ml ropivacaine infused from autofuser in that time period).20% lipids were administered (350ml) and patient's mental status returned to baseline.".
Additional Manufacturer Narrative
(b)(4).Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review was performed based upon a potential lot number from sales history data and no relevant findings were identified.The potential cause of this complaint could not be determined based upon the information provided and without a sample.No further action required at this time.Teleflex will continue to monitor and trend on complaints of this nature.
Event or Problem Description
It was reported that while in use on a patient, "the autofuser was set to 8ml per hour and the autofuser emptied completely in 24 hours.The patient had a wound vac on".No patient harm or injury.The patient status is reported as "fine".Additional information received stated that the "patient was somnolent after 24 hours of infusion (500ml ropivacaine infused from autofuser in that time period).20% lipids were administered (350ml) and patient's mental status returned to baseline.".

• 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: 17342613
• Report Number: 3004365956-2023-00047
• Device Sequence Number: 6894079
• 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: UNKNOWN
• Was Device Available for Evaluation?: No
• 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): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: N/A.; N/A.
• Patient Sex: Unknown