MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2C6671
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/12/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that the filter of an interlink solution administration set filled with air and leaked total parenteral nutrition (tpn) from the end of the tubing.This event occurred while priming the device.It was further reported that once the device leaked it was then reprimed and the filter was adjusted.The device leaked tpn solution again.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A priming test was performed and the device passed with no issues noted.Pressure testing and clear passage testing under water were performed, and the device did not leak.Functional testing was performed on the filter, and the filter passed the testing with no issues noted.The reported condition was not verified.The device was found to operate per specification.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SOLUTION ADMINISTRATION SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 7614277
• Report Number: 1416980-2018-03711
• Device Sequence Number: 19406207
• Product Code: FPA
• UDI-Device Identifier: 00085412003993
• UDI-Public: (01)00085412003993
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/20/2018

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: 02/18/2023
• Device Catalogue Number: 2C6671
• Device Lot Number: R18B18032
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2018
• Initial Date Received by Manufacturer: 05/23/2018
• Supplement Date Received by Manufacturer: 07/09/2018
• Initial Report FDA Received Date: 06/19/2018
• Supplement Report FDA Received Date: 07/20/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1