MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 28 CM (11") ADD-ON SET W/CHECK VALVE, VENTED CAP; STOPCOCK, I.V. SET

Catalog Number 011-H3395

Device Problem No Flow (2991)

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

Event Date 02/22/2024

Event Type  malfunction  

Manufacturer Narrative

Three (3) new samples #011-h3395 were returned for evaluation.As received no physical damage or anomalies were observed.The sets were tested as per procedure and met product specification, no issues or anomalies were confirmed.Complaint of no flow / can¿t prime / difficult to prime cannot be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

Event Description

The event involved 28 cm (11") add-on set w/check valve, vented cap where the customer reported a no flow issue during patient infusion of pembrolizumab the bag did not empty.There were no leaks during the event.The customer reported concern about several patients, with several nurses, on several products, at different times of the day.The customer reported that the clinical consequence was delay in patients¿ support.There was a 1 hour delay in therapy.There was no suspicion of infection associated with care.The therapy was completed after change the line with another lot.It was stated that the perfusion of the bags was not done correctly for all of these molecules and patients.There were no negative clinical consequences following this event.There was no need for additional medical interventions.

• Brand Name: 28 CM (11") ADD-ON SET W/CHECK VALVE, VENTED CAP
• 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: 18980232
• MDR Text Key: 338621190
• Report Number: 9617594-2024-00340
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619058067
• UDI-Public: (01)00840619058067(17)280801(10)13730999
• 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: 02/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3395
• Device Lot Number: 13730999
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2024
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2023
• 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