BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1820282 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02860
    Event Type
    Malfunction
    Date Received
    August 30, 2010
    Date of Event
    July 20, 2010
    Report Date
    August 4, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K982102
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TW
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE CUSTOMER, THE DEVICE IS AVAILABLE FOR EVALUATION; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. A FOLLOW-UP REPORT WILL BE SUBMITTED SHOULD THE DEVICE BE RECEIVED AND EVALUATED OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE DEVICE WAS RECEIVED BY BAXTER FOR EVALUATION. A VISUAL EXAMINATION AND FUNCTIONAL TESTS WERE PERFORMED. DEVICE EVALUATION COULD NOT CONFIRM THE REPORTED CONDITION OF AN OVERINFUSION. THE ROOT CAUSE COULD NOT BE DETERMINED. THIS DEVICE IS A SINGLE USE DEVICE AND WAS DISCARDED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT SIX SINGLE DAY INFUSOR DEVICES OVERDELIVERED DURING USE. THIS IS REPORT NUMBER 3 OF 6. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Description of Event or Problem · 1

    A HOME PATIENT (HP) CONTACTED GLOBAL TECHNICAL SERVICES REQUESTING ASSISTANCE WITH STARTING OVER WITH NEW SUPPLIES ON THE HOME CHOICE (HC) MACHINE. THE HP EXPLAINED HE MAY HAVE CONTAMINATED THE PATIENT LINE CONNECTING THE EXTENSION LINE AND WANTED TO START OVER WITH NEW SUPPLIES. THE TECHNICAL SERVICE REPRESENTATIVE HAD THE HP CYCLE POWER TO START OVER WITH NEW SUPPLIES. A FOLLOW UP WITH THE CARE GIVER (CG) WAS DONE BY PHONE. THE CG SAID THEY WERE TOLD BY BAXTER NOT TO TAKE ANY CHANCES AND TO START OVER WITH NEW SUPPLIES. PER THE CG, THEY SET UP WITH NEW SUPPLIES AND THE HP CONTINUED THERAPY WITHOUT ANY PROBLEMS. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR SINGLEDAY 2ML/HR 12PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10A019

    Patients

    Seq Age Sex Outcome Treatment
    1