BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CLEARSTAR PUMP

    MDR report key: 1030650 · Received April 15, 2008

    Report

    Report Number
    1527460-2008-00751
    Event Type
    Malfunction
    Date Received
    April 15, 2008
    Manufacturer
    ROSS PRODUCTS DIVISION
    Product Code
    LZH
    PMA / PMN Number
    K981541
    Removal / Correction Number
    Z-1142-2007
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LAB EVALUATION CONFIRMED A BROKEN ADAPTER BRACKET. ROSS STANDARD PROCEDURE INCLUDES ATTEMPTING TO OBTAIN ALL REQUIRED INFO FROM THE SOURCE. BECAUSE THIS PUMP WAS RETURNED TO ABBOTT AS PART OF A RECALL AND WAS NOT ASSOCIATED WITH AN INITIAL REPORTER.

    Description of Event or Problem · 1

    CRACKED OR BROKEN ADAPTER BRACKET.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CLEARSTAR PUMP LZH PUMP, INFUSION, ENTERAL LZH ROSS PRODUCTS DIVISION 55239

    Patients

    Seq Age Sex Outcome Treatment
    1