BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    6461500 INFUSOR PUMP (1 LABEL)

    MDR report key: 1920390 · Received December 10, 2010

    Report

    Report Number
    6000001-2010-05735
    Event Type
    Malfunction
    Date Received
    December 10, 2010
    Date of Event
    September 1, 2010
    Report Date
    September 29, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    PMA / PMN Number
    K885377
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). A FOLLOW-UP MEDWATCH REPORT WILL BE SUBMITTED WHEN THE EVALUATION RESULTS OR IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: THE REPORTED CONDITION WAS CONFIRMED. THE ASSIGNABLE CAUSE WAS AN OUT OF ADJUSTMENT OCCLUSION SWITCH. THE OCCLUSION SWITCH HAS BEEN READJUSTED. ADDITIONAL: A SERVICE HISTORY REVIEW REVEALED THAT THIS DEVICE WAS NOT PREVIOUSLY SERVICED PRIOR TO THIS EVENT.

    Additional Manufacturer Narrative · 1

    (B)(4). THE ALERT AND OCCURENCE DATES WERE INACCURATE IN THE INITIAL MEDWATCH REPORT. THE ACCURATE DATE FOR BOTH THE ALERT DATE AND OCCURRENCE DATE IS (B)(6) 2010.

    Additional Manufacturer Narrative · 1

    (B)(4), 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.

    Description of Event or Problem · 1

    THE FACILITY REPRESENTATIVE REPORTED A INFUSOR PUMP WITH A CONDITION OF "DROPPED IT AND NOW IT WON'T WORK". IT IS UNKNOWN WHEN THIS CONDITION OCCURRED. DURING BAXTER'S PRODUCT EVALUATION, IT WAS DISCOVERED THAT THERE WAS A FALSE OCCLUSION ALARM. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION NECESSARY ACCORDING TO THE HOSPITAL REPRESENTATIVE. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 6461500 INFUSOR PUMP (1 LABEL) PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1