BEUDAMED
    FDA Adverse Event Summary report: N

    COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL

    MDR report key: 1633035 · Received March 17, 2010

    Report

    Report Number
    6000001-2010-00314
    Date Received
    March 17, 2010
    Date of Event
    March 10, 2010
    Report Date
    March 10, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K063696
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DURING SERVICE AT BAXTER, A TECHNICIAN REPORTED ON (B)(6) 2010 FINDING A COLLEAGUE INFUSION PUMP WITH AN INOPERATIVE STOP KEY ON THE PUMPHEAD MODULE KEYPAD. THE PUMPHEAD MODULE KEYPAD WAS REPLACED.

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4). THERE IS A CAPA (CORRECTIVE AND PREVENTIVE ACTION) INVESTIGATION ASSOCIATED WITH THIS REPORT, (B)(4) .

    Additional Manufacturer Narrative · 1

    COMPLAINT NO: (B)(4).

    Description of Event or Problem · 1

    DURING SERVICE AT BAXTER, A TECHNICIAN REPORTED ON (B)(6) 2010 FINDING A COLLEAGUE INFUSION PUMP WITH AN INOPERATIVE STOP KEY ON THE PUMPHEAD MODULE KEYPAD. THIS EVENT OCCURRED DURING PRODUCT EVALUATION ON (B)(6) 2010. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY. THE USER INTERFACE MODULE MASTER SOFTWARE VERSION IS 5.09.90, CATEGORIZED AS REMEDIATED.NO ADDITIONAL INFORMATION IS AVAILABLE.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING ERRONEOUSLY ELEVATED TSH AND PSA RESULTS GENERATED BY THE ACCESS 2 IMMUNOASSAY SYSTEM. ALL SAMPLES WERE REPEATED AND RECOVERED RESULTS WITHIN THE NORMAL REFERENCE RANGE. NO REPORTS OF DEATH, INJURY, OR CHANGE TO PATIENT TREATMENT HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.

    Description of Event or Problem · 1

    TECHNICIAN ALLEGED BRAKES WOULD ENGAGE AND HOLD, HOWEVER, CASTER WOULD STILL SLIGHTLY SWIVEL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE CX VOLUMETRIC INFUSION PUMP SINGLE CHANNEL PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1