MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 0.2 MICRON PEDIATRIC FILTER, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B6008

Device Problem Fluid/Blood Leak (1250)

Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not available to be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The customer reported a 0.2 micron filter that leaked chemotherapy (temsirolimus) from a crack along the edge of the filter (where the filter connects to the infusion set).The line was primed with 0.9% normal saline pre, with no leaking noted at this time; chemotherapy was started.At the end of the infusion (30 ¿ 60 minutes), the rn was called to the room to hang the flush and noticed the bedding was saturated with chemotherapy.The infusion was stopped, a spill kit was obtained, and the patient¿s bedding was changed.The patient¿s port was heparin locked and the decision was made not to repeat the dose as it was unknown when the leak began and how much of the drug the patient received.There was patient involvement, no blood loss or bleed back and no patient harm reported.

• Brand Name: 0.2 MICRON PEDIATRIC FILTER, 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 11108751
• MDR Text Key: 251541620
• Report Number: 9617594-2021-00001
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709011014
• UDI-Public: (01)00887709011014(17)250201(10)4711117
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B6008
• Device Catalogue Number: B6008
• Device Lot Number: 4711117
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/01/2020
• 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