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

Catalog Number 2N3342

Device Problem Obstruction of Flow (2423)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/04/2020

Event Type  malfunction  

Manufacturer Narrative

The device was evaluated.Unaided visual inspection was performed and all components were correctly placed and according to specifications.Functional testing including pressure and clear passage tests were performed; no leak was found.However, a blockage was identified in the micron low volume filter component; the device was primed and the flow was not normal.The filter was disassembled to perform a closer inspection.Traces of yellow solution was found in the top membrane of the filter.No yellow solution is used during the manufacturing of the device.The cause of the yellow solution trace could not be determined; however probable cause is related to user.A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

During evaluation of a non-dehp three lead extension set, the filter was found blocked resulting in abnormal flow.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: MICRO-VOLUME EXTENSION SET
• Type of Device: FILTER, INFUSION LINE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina, san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 10344854
• MDR Text Key: 201028952
• Report Number: 1416980-2020-04558
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 00085412004778
• UDI-Public: (01)00085412004778
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: K113227
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2N3342
• Device Lot Number: DR19L12034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/15/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/21/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/13/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1