MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS; STOPCOCK, I.V. SET

Catalog Number 011-H1922-10

Device Problem Excess Flow or Over-Infusion (1311)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/08/2024

Event Type  malfunction  

Event Description

The event involved a 43 cm (17") transfer set, pur w/clave¿, 10 units where it was reported the infusion time is higher than the desired infusion time.¿ the status of the product at the time of the event is during infusion.There were at least 3 incidents.The product was administrated in 1 hour instead of the 30 minutes planned.The filter extension was correctly connected.There was no human harm.The patient was in good condition before, during and after the incident.No clinical consequence on the patient.No need for medical intervention.There was no delay in therapy, just an extension of the infusion time, therefore a longer consultation for the patient.The bag was prepared on site.The planned duration for pembrolizumab was 30 minutes but the final duration was 1 hour.This is the second of three incidents reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

• Brand Name: 43 CM (17") TRANSFER SET, PUR W/CLAVE¿, 10 UNITS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18919060
• MDR Text Key: 337853755
• Report Number: 9617594-2024-00273
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709123953
• UDI-Public: (01)00887709123953(17)280301(10)13558622
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/16/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H1922-10
• Device Lot Number: 13558622
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/15/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/14/2024
• 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