MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 43 CM (17") TRANSFER SET W/CLAVE® (GREEN RING), 0.2 MICRON FILTER, 2 CLAMPS, CHE; STOPCOCK IV SET

Catalog Number 011-H3210

Device Problem Air/Gas in Device (4062)

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

Event Date 10/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unspecified date and involved a 43 cm (17") transfer set w/clave® (green ring), 0.2 micron filter, 2 clamps, check valve w/luer lock.The customer reported that during patient use, there was no problem noticed at the start of the infusion but then air bubbles form in the tubing.The nurse stopped the infusion and primed the line but cannot resume the infusion.The patient did not receive all his chemotherapy but there was no delay due to the stop of the therapy, the device was no replaced.No defects were observed during the various checks.There was no blood loss considered clinically significant.There was no need for additional medical intervention.The pump connected at the time of the event was an agilia one.No problems noted with the pump.No other information was provided.

Manufacturer Narrative

The device is not available for investigation as the customer has discarded it.Without the return of the device, a probable cause is unable to be determined.

• Brand Name: 43 CM (17") TRANSFER SET W/CLAVE® (GREEN RING), 0.2 MICRON FILTER, 2 CLAMPS, CHE
• Type of Device: STOPCOCK IV 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: 18038151
• MDR Text Key: 326953249
• Report Number: 9617594-2023-00896
• 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
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H3210
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2023
• 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: INFUSION PUMP, AGILIA; UNSPECIFIED MEDICATION, MFR UNK