BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTERLINK SYSTEM BASIC SOLNSET INJ SITE

    MDR report key: 2062787 · Received April 19, 2011

    Report

    Report Number
    6000001-2011-02966
    Event Type
    Malfunction
    Date Received
    April 19, 2011
    Date of Event
    April 1, 2011
    Report Date
    April 5, 2011
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FPA
    PMA / PMN Number
    K961225
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS RECEIVED FOR EVALUATION ON 04/28/2011. AN ACTUAL SAMPLE WAS RECEIVED FOR EVALUATION. THE SAMPLE ARRIVED PRIMED AND SPIKED INTO AN EMPTY 2B1322 0.9% SODIUM CHLORIDE SOLUTION BAG. THE SAMPLE WAS REMOVED FROM THE EMPTY BAG AND SPIKED INTO A 1000ML SOLUTION BAG CONTAINING STERILE WATER. THE SAMPLE WAS RE-PRIMED AND NO AIR IN-LINE WAS OBSERVED DURING PRIMING AND FLOW. THE SAMPLE WAS THEN SUBMITTED FOR AN UNDER WATER LEAK TEST AND NO LEAKS WERE OBSERVED. SINCE THE SAMPLE PRIMED AND FLOWED NORMALLY WITH NO LEAKS OR AIR IN-LINE FOUND, THE REPORTED WAS NOT CONFIRMED AND NO ROOT CAUSE WAS IDENTIFIED. A BATCH REVIEW COULD NOT BE COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED BY THE CUSTOMER. 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.

    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.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED TO BAXTER AN INTERLINK SYSTEM BASIC SOLUTION SET IN WHICH AN AIR IN LINE OCCURRED. ACCORDING TO THE REPORT, THE NURSE WAS ATTEMPTING TO INFUSE VANCOMYCIN ON A PATIENT VIA GRAVITY AND SMALL AIR BUBBLES KEPT APPEARING IN THE TUBING. THE CONDITION OCCURRED DURING INFUSION ON A PATIENT. THERE WAS NO 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 SYSTEM BASIC SOLNSET INJ SITE SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 VANCOMYCIN