MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 18" (46 CM) APPX 5.1 ML, EXT SET W/0.2 MICRON FILTER, CLAVE, SPIROS, CLAMP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	CH3556
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It is unknown if the device will be returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.Additional contact person of ufmw ¿(b)(6).
Event or Problem Description
A medsun mandatory medwatch report (uf/importer reporter # (b)(4) was received which stated the following: ¿patient receiving iv hydration with standard iv 3 port tubing and chemo filter.Rn put together tubing set for upcoming chemotherapy infusion.Once connected, the spiros filter line was leaking at the spiros cap (18¿ ext set w/0.2 micron filter clave, spiros, clamp).After this was discovered, replaced iv tubing with new line set up.¿ it was also reported that the original intended procedure was chemotherapy infusion and that the device failed (e.G broke, couldn¿t get it to work or stopped working), the event happened at hospital in the patient¿s room and the approximate age of the device was 1 day.The event occurred on an unknown date in (b)(6) 2020.

• Brand Name: 18" (46 CM) APPX 5.1 ML, EXT SET W/0.2 MICRON FILTER, CLAVE, SPIROS, CLAMP
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• 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: 10871757
• Report Number: 9617594-2020-00512
• Device Sequence Number: 2521747
• Product Code: FPA
• UDI-Device Identifier: 00887709076341
• UDI-Public: (01)00887709076341(17)250801(10)4949284
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Report Source: user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/27/2020

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: 08/01/2025
• Device Catalogue Number: CH3556
• Device Lot Number: 4949284
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 11/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 14 YR