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

Catalog Number 2N3342

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/31/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event 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.

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
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 10583174
• MDR Text Key: 208501018
• Report Number: 1416980-2020-05930
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (y/n): Y
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 10/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/24/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2N3342
• Device Lot Number: DR19L12034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/22/2020
• Date Manufacturer Received: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: TPN LINES (UNSPECIFIED)