MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION MICRO-VOLUME EXTENSION SET; FILTER, INFUSION LINE

Catalog Number	2N3342
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/31/2020
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 tri-furcated filters of two (2) non-dehp three lead extension sets were discolored.It was further reported that there was brown sediment observed in the filters.This issue was identified during patient infusions.The sets were being used on tpn lines (total parenteral nutrition).There was no report of patient injury or medical intervention associated with these events.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to d10, h3, h4, and h6.H10: two (2) devices were received for evaluation.A visual inspection was performed, and it was noted that there was yellowish discoloration in the micron low volume filter.All components were correctly placed and according to specifications.Additionally, functional testing was performed including pressure and clear passaged testing.During functional testing, there was no leak noted; however, a blockage was discovered in the micron low volume filter.The reported condition was verified.The cause of the reported condition could not be determined; however, a probable cause may have been a user error as the yellow discoloration resembled spherical particles suggestive of a mixture of amino acids which would be consistent with tpn solution residue, which also could block the filter.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: MICRO-VOLUME EXTENSION SET
• Common Device Name: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10583174
• Report Number: 1416980-2020-05930
• Device Sequence Number: 10838894
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K113227
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 12/13/2024
• Device Catalogue Number: 2N3342
• Device Lot Number: DR19L12034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Initial Date Received by Manufacturer: 08/31/2020
• Supplement Date Received by Manufacturer: 10/13/2020
• Initial Report FDA Received Date: 09/24/2020
• Supplement Report FDA Received Date: 10/28/2020
• 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: TPN LINES (UNSPECIFIED)