BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR SINGLEDAY 2ML/HR 12PK

    MDR report key: 1820252 · Received August 30, 2010

    Report

    Report Number
    6000001-2010-02857
    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). 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.

    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.

    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 6 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

    IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A PROLIEVE THERMODILATATION SYSTEM KIT WAS USED DURING A PROCEDURE (DATE UNKNOWN) AS A PART OF A POST-MARKET STUDY TO TREAT BENIGN PROSTATIC HYPERPLASIA (BPH). DURING A POSTOPERATIVE VISIT ON (B)(6) 2010, THE SUBJECT WAS FOUND TO HAVE AN ELEVATED PROSTATE-SPECIFIC ANTIGEN (PSA) AND WAS TREATED WITH A TWO WEEK COURSE OF CIPRO FOR POSSIBLE PROSTATITIS. SEVERAL ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION HAVE BEEN UNSUCCESSFUL.

    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