BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM

    MDR report key: 2012190 · Received March 9, 2011

    Report

    Report Number
    6000001-2011-01734
    Event Type
    Malfunction
    Date Received
    March 9, 2011
    Date of Event
    March 1, 2011
    Report Date
    March 1, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE IS REPORTED TO BE AVAILABLE FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR ADDITIONAL INFORMATION BECOMES AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 04/11/2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. A VISUAL INSPECTION OF THE SAMPLE DID NOT REVEAL ANY OBVIOUS DEFECTS. THE SAMPLE WAS THEN SPIKED INTO A 1000ML SOLUTION BAG AND RE-PRIMED, AND A LEAK OCCURRED NEAR THE SECOND Y-SITE. A VISUAL INSPECTION UNDER A MICROSCOPE REVEALED A CUT IN THE TUBING AT THE IN-LET PORT. THE SAMPLE WAS THEN UNDERWATER LEAK TESTED. THE REPORTED CONDITION WAS CONFIRMED. ALTHOUGH THE REPORTED CONDITION WAS CONFIRMED, THE ROOT CAUSE WAS NOT IDENTIFIED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN INTERLINK CONTINU-FLO SOLUTION SET THAT HAD A HOLE IN THE UPPER Y-SITE. THE CONDITION WAS IDENTIFIED WHILE ATTEMPTING TO SET UP A PIGGYBACK DURING PATIENT USE. IT IS UNKNOWN IF THERE WAS ANY PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTERLINK(TM)CONTINU-FLO SOLNSET 3INJ SITES 10DPM SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE SR10L16059

    Patients

    Seq Age Sex Outcome Treatment
    1