MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number MC9013

Device Problem Fluid/Blood Leak (1250)

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

Event Date 10/08/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not 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 event involved a 14¿ ext set w/0.2 micron filter, clave ¿ clear, clamp, rotating luer where a leak of chemotherapy was noted.It was reported that the final chemotherapy, cisplatin, (of dicep chemotherapy) had just been started at 659 ml an hour; the patient complained of feeling something wet on her legs and on her gown.It was also reported that the infusion was stopped, and a leak of chemotherapy could be seen at the side of a 0.2 micron filter.A new filter was used for the remainder of the infusion and the patient¿s skin was washed and her clothing was changed.There was no blood loss or bleed back reported.There were no obvious defected noted on the tubing set.There was patient involvement, and a report of unprotected chemotherapy exposure to the healthcare provider or the patient; but no apparent harm was reported.

• Brand Name: 14" EXT SET W/0.2 MICRON FILTER, CLAVE CLEAR, 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 10859995
• MDR Text Key: 219567143
• Report Number: 9617594-2020-00498
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709039391
• UDI-Public: (01)00887709039391(17)250601(10)4896097
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 10/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MC9013
• Device Catalogue Number: MC9013
• Device Lot Number: 4896097
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/26/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2020
• 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