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

Catalog Number	2C1103
Medical Device Problem Codes	Complete Blockage (1094); No Flow (2991)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).The user facility submitted a medwatch report for this event: mw5082910-1.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that two (2) interlink solution sets were clogged and would not flow.This was observed during infusion with 20% fat emulsions as part of parenteral nutrition.There was no patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Four (4) actual samples and one hundred-fifty (150) companion samples were received for evaluation.Visual inspection of the 4 actual samples and companion samples did not identify any abnormalities that could have contributed to the reported condition.Sample analysis of the 4 actual used samples including pressure test and clear passage under water test were performed.It was verified there was an obstructed assembly between the tubing and the filter due to excess of solvent for the actual samples.The assembly between the filter and the tubing were per specification, no excess of solvent was observed in the component unions.The reported condition was verified for the 4 actual samples.The cause of the condition could not be determined.The membrane of the 4 used filters were also examined and compared with a membrane of a non-used filter.No significant differences were observed between the membranes of the used filters and the membranes of the unused filter; no visual defect was observed.The reported condition was not verified for the companion samples.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 SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8400557
• Report Number: 1416980-2019-01243
• Device Sequence Number: 312332
• Product Code: FPA
• UDI-Device Identifier: 00085412000503
• UDI-Public: (01)00085412000503
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K952074
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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: 07/05/2023
• Device Catalogue Number: 2C1103
• Device Lot Number: R18G05087
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/06/2019
• Initial Report FDA Received Date: 03/07/2019
• Supplement Report FDA Received Date: 04/11/2019
• 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: INTRALIPID 20% AND/OR SMOFLIPID 20%