MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK FENWAL 40/150 MICRON DUAL SCREEN FILTER; FILTER, INFUSION LINE

Catalog Number 4C6838

Device Problems Defective Component (2292); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Lot number reported as "795864"; however, this is not a valid baxter lot number.The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported interlink system y-type blood/solution set was allowing particles past the filter.It was further reported unspecified particulate "larger than 40-150um" were observed "after the blood filter".The event occurred during an unknown process step prior to patient involvement.No additional information is available.

• Brand Name: INTERLINK FENWAL 40/150 MICRON DUAL SCREEN FILTER
• 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: 10779119
• MDR Text Key: 214367085
• Report Number: 1416980-2020-06822
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): Y
• Reporter Country Code: SN
• PMA/PMN Number: K932301
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 4C6838
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/07/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1