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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	12/04/2020
Type of Reportable Event	Malfunction
Additional 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 or Problem 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
• Common Device Name: 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
• MDR Report Key: 11108751
• Report Number: 9617594-2021-00001
• Device Sequence Number: 3596020
• Product Code: FMG
• UDI-Device Identifier: 00887709011014
• UDI-Public: (01)00887709011014(17)250201(10)4711117
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K964435
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/01/2025
• Device Model Number: B6008
• Device Catalogue Number: B6008
• Device Lot Number: 4711117
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/09/2020
• Initial Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1