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

Model Number IPN924713

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem Lethargy (2560)

Event Date 06/22/2023

Event Type  Injury  

Event 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.".

Manufacturer Narrative

(b)(4).Other remarks: n/a.Corrected data: n/a.

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 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
• Type of Device: 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
• MDR Text Key: 319381077
• Report Number: 3004365956-2023-00047
• Device Sequence Number: 1
• Product Code: MEB
• UDI-Device Identifier: 14026704743541
• UDI-Public: 14026704743541
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090300
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/26/2023
• Initial Date FDA Received: 07/18/2023
• Supplement Dates Manufacturer Received: 08/14/2023
• Supplement Dates FDA Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: N/A.; N/A.