MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PLUMSET-W/2 CLAVE 1'S; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1203012
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is not complete.
Event or Problem Description
The event involved a plumset that leaked 3-4 drops of ifosfamide when infused over 24 hours.The customer reported that there were no obvious defects noted on the tubing set; no hole, cut, tears or any other defects noted.The tubing was not replaced and therapy was not resumed.There was no adverse event reported.
Additional Manufacturer Narrative
The reported leak was not confirmed by investigation.One used lifeshield primary plumset clave port clave y-site 104 inch set was received for investigation.As received, the set was attached to a used bag spike adapter w/spiros and a used chemoclave vented bag spike and was visually inspected and no defects were observed.The returned set and attached configuration was leak tested per the product specifications and no leaks were observed.The plumset performed as required per the product specifications.A batch record review was performed to lot 841745h list 120300412 and no discrepancies that may have contributed to a complaint of this nature were found.

• Brand Name: PLUMSET-W/2 CLAVE 1'S
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• MDR Report Key: 8588568
• Report Number: 9615050-2019-00144
• Device Sequence Number: 19381231
• Product Code: FPA
• UDI-Device Identifier: 10887787005193
• UDI-Public: (01)10887787005193(17)201201(10)841745H
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K141789
• 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,Followup
• Report Date (Section B): 04/18/2019

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: 12/01/2020
• Device Model Number: 1203012
• Device Catalogue Number: 120300412
• Device Lot Number: 841745H
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 04/25/2019
• Initial Date Received by Manufacturer: 04/18/2019
• Supplement Date Received by Manufacturer: 05/16/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 05/29/2019
• 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: IFOSFAMIDE, MFR UNK