MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 183 CM (72") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 4 ACCESSI CON BCV, CAMERA,; STOPCOCK, I.V. SET

Catalog Number 011-H2532

Device Problems Fluid/Blood Leak (1250); Component Misassembled (4004)

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

Event Date 11/17/2023

Event Type  malfunction  

Manufacturer Narrative

The device was unable to be returned as it was considered biohazard.The device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.

Event Description

The event involved a 183 cm (72") pur set d'infusione, perf.Con valvola, 4 accessi con bcv, camera, filtro 15¿, rub.Con clave¿, ll gir.The customer reported mismatch of one of the routes of the chemotherapy tubing between the 'var' and the tubing, causing a leak of the chemotherapy product to the ground and requiring the repreparation of the bag for the patient.The event was observed during use on a patient, at the beginning of the administration.There was a delay in therapy due to the need to redo the chemo bag.The drug administrated was carboplatin.The patient received the full intended dose, but with the new bag.There was no undesirable clinical consequences, and nobody was hurt as a consequence of this event.

• Brand Name: 183 CM (72") PUR SET D'INFUSIONE, PERF. CON VALVOLA, 4 ACCESSI CON BCV, CAMERA,
• 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: 18328297
• MDR Text Key: 330668262
• Report Number: 9617594-2023-01159
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619019303
• UDI-Public: (01)00840619019303(17)280401(10)13611398
• 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: 12/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-H2532
• Device Lot Number: 13611398
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/17/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: CARBOPLATIN, MFR UNK