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  

Manufacturer Narrative

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

Event Description

The complaint/event involved a 21 cm (8") ext set w/0.2 micron filter, microclave®, clamp, rotating luer.The customer reported that occlusion occurred few ml from the end of a chemotherapy infusion (55 minutes after the start of treatment) with the use of a fresenius pump.There was 15 minutes delay in therapy and the therapy was completed.They stated that the issue was even observed with 'free flow'.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 durvalumab imfinzi ¿ nacl 0,9% 250ml perfusion 1h00.The patient received the full intended dose.There was no adverse clinical consequences or harm as a result of the reported event.

Manufacturer Narrative

One used sample item #011-h3668 connected to an unknown, 0.9% nacl 250ml bag were returned for evaluation.As received no physical damage or anomalies were observed.The sample was leaked tested as per procedure and met product specification.No occlusion, damage or anomalies were observed.The complaint of no flow / can't prime / difficult to prime was not able to be confirmed or replicated.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.Date returned to mfg:14dec2023.

• 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. IL
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18309686
• MDR Text Key: 330273847
• Report Number: 9617594-2023-01121
• Device Sequence Number: 1
• Product Code: FMG
• 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,Followup
• Report Date: 01/31/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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: 01/24/2024
• 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: DURVALUMAB IMFINZI, NACL 0,9%, MFR UNK.; UNSPECIFIED PUMP, MFR FRESENIUS.
• Patient Age: 71 YR
• Patient Sex: Male