BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCESS

    MDR report key: 2404730 · Received January 9, 2012

    Report

    Report Number
    6000001-2012-01675
    Event Type
    Malfunction
    Date Received
    January 9, 2012
    Date of Event
    December 1, 2011
    Report Date
    December 19, 2011
    Manufacturer
    BAXTER HEALTHCARE - AIBONITO
    Product Code
    FPA
    PMA / PMN Number
    K940867
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE SAMPLE WAS NOT AVAILABLE HENCE THE ROOT CAUSE CANNOT BE DETERMINED. NO CONCLUSION CAN BE DRAWN FROM THE INVESTIGATION. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW COULD NOT BE PERFORMED AS THE LOT NUMBER OF THIS DEVICE IS UNKNOWN. IF ADDITIONAL INFORMATION OR SAMPLES BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    (B)(4). A LABELING REVIEW WAS PERFORMED AND THE INSTRUCTIONS PRINTED ON EACH INDIVIDUAL PACKAGING ARE AVAILABLE TO THE USER AND ARE ACCURATE AND SUFFICIENT.

    Description of Event or Problem · 1

    A CUSTOMER REPORTED TO BAXTER CORPORATE PRODUCT SURVEILLANCE A CLEARLINK SYSTEM CONTROL-A-FLO EXTENSION SET WHICH "HAD FALLEN APART." THE BAXTER SALES REPRESENTATIVE (BSR) EXPLAINED THAT THE FACILITY IS SWITCHING FROM HOSPIRA DIAL-FLO SET TO BAXTER SETS. BSR SPECULATES THE CUSTOMER DID NOT PRIME THE SET PROPERLY. ACCORDING TO THE REPORT, THE CUSTOMER WAS PRIMING WITH SALINE AND "MOST LIKELY TRIED TO FLUSH WITH PRESSURE ABOVE THE CONTROL-A-FLO." BSR SPECULATES "FOR WHATEVER REASON CUSTOMER USED PRESSURE ABOVE THAT DEVICE, EITHER WITH AN IV PRESSURE PUMP OR THEY TRIED TO PRIME WITH PRESSURE ABOVE, INSTEAD OF BELOW, THAT PORT." THEREFORE "CAUSED DIAPHRAGM TO SPLIT AND MAYBE OPEN UP." BSR RELAYED HE SPOKE WITH MATERIALS MANAGEMENT, SUPPLIED THEM WITH A POSTER, AND WILL BE GOING ONSITE TO FOLLOW UP IN PERSON. THE WAS NO PATIENT INVOLVEMENT, INJURY, MEDICAL INTERVENTION, OR ADVERSE EVENT ASSOCIATED WITH THIS REPORT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCESS SET, ADMINISTRATION, INTRAVASCULAR FPA BAXTER HEALTHCARE - AIBONITO

    Patients

    Seq Age Sex Outcome Treatment
    1