MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 21 CM (8") EXT SET W/0.2 MICRON FILTER, MICROCLAVE®, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Catalog Number 011-H3668

Device Problem No Flow (2991)

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

Event Date 11/16/2023

Event Type  malfunction  

Event Description

The incident involved a 21 cm (8") ext set w/0.2 micron filter, microclave®, clamp, rotating luer.The customer reported that they encounter occlusion a few ml from the end of the infusion with the use of fresenius pumps during the infusion of chemotherapy.The problem persists even with ¿free flow¿.The customer stated the patient was connected to the device at the time of the event.The event happened 24 minutes after the start of treatment.There was 15 minutes delay in therapy, and the therapy was completed.There were no adverse clinical consequences following this incident.There was no blood loss considered clinically significant.There was no physical defect on the device before the incident.There was no unprotected exposure to any cytotoxic product for the patient or healthcare professional.The drug administrated was pembrolizumab keytruda 200mg ¿ nacl 0,9% 100ml perfusion 0h30.The patient received the full intended dose.

Manufacturer Narrative

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

Manufacturer Narrative

D9 - date returned to mfg on 12/14/2023.Received one new 011-h3668 ext set for inspection.No damages or anomalies noted.The set was primed at gravity pressure and water flowed as expected.No occlusion was observed.The complaint of occlusion a few ml from the end of the infusion was not able to be replicated or confirmed.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: 21 CM (8") EXT SET W/0.2 MICRON FILTER, MICROCLAVE®, CLAMP, ROTATING LUER
• 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: 18219757
• MDR Text Key: 329152164
• Report Number: 9617594-2023-01036
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619075675
• UDI-Public: (01)00840619075675(17)280501(10)13643269
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: UNKNOWN
• 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,Followup
• Report Date: 02/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3668
• Device Lot Number: 13643269
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/01/2023
• 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
• Treatment: NACL 0,9% 100ML PERFUSION 0H30, MFR UNK; PEMBROLIZUMAB KEYTRUDA 200MG, MFR UNK; UNSPECIFIED INFUSION PUMP, FRESENIUS
• Patient Age: 56 YR
• Patient Sex: Male