MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. NONVENTED PLUM SET 1'S; ADMINISTRATION SET

Model Number	1187912
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Na.
Event or Problem Description
The event occurred on an unknown date and involved a plum set with leakage on the filter.This record captures the first of two devices.The reported filter leak was confirmed by investigation.One (1) used list plum set was received for investigation.As received, the returned set was visually inspected and the filter vent was observed to be wetted and/or saturated.The reported infusate was taxol.The returned set was leak tested per the product specifications and a leak was observed from the filter vent of the filter of the returned sets.Red dyed water was used to analyze the origin and mode of the replicated filter vent leak.The leak appeared to seep through the filter vent material from various locations.The probable cause of the observed filter vent leak is temporary or permanent loss of the hydrophobic properties due to infusate interactions.

• Brand Name: NONVENTED PLUM SET 1'S
• Common Device Name: ADMINISTRATION SET
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8657582
• Report Number: 9615050-2019-00172
• Device Sequence Number: 11337524
• Product Code: FRN
• UDI-Device Identifier: 10887787009023
• UDI-Public: (01)10887787009023(17)210801(10)928085H
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K982159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/04/2019

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: 08/01/2021
• Device Model Number: 1187912
• Device Catalogue Number: 118790412
• Device Lot Number: 928085H
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2019
• Initial Report FDA Received Date: 05/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: TAXOL UNK MFG