BEUDAMED
    FDA Adverse Event Death Summary report: N

    PCA MICROJET PUMP

    MDR report key: 976661 · Received December 28, 2007

    Report

    Report Number
    1722214-2007-00020
    Event Type
    Death
    Date Received
    December 28, 2007
    Date of Event
    June 6, 2006
    Report Date
    December 21, 2007
    Manufacturer
    SORENSON MEDICAL, INC.
    Product Code
    MEA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    REPORTER STATED THAT A DEATH OF A PATIENT OCCURRED IN 2006. INVESTIGATION OF RETURNED PRODUCT: MICROJET PUMP: CONCLUSION: THE MICROJET PUMP OPERATED WITHIN THE MANUFACTURING SPECIFICATIONS. BASED ON THE TREND ANALYSIS OF THE COMPLAINT SYSTEM, IT WOULD APPEAR THAT IS NOT A SYSTEMIC PROBLEMS WITH LOT. THE MICROJET PUMPS HAVE NOT BEEN SOLD/DISTRIBUTED SINCE DEC. 31, 2004. MICROJET CASSETTE: THE MICROJET CASSETTE DID NOT PERFORM TO MANUFACTURING SPECIFICATIONS. THE PERFORMANCE WAS BELOW THE REQUIRED SPECIFICATIONS WHICH WOULD CAUSE UNDER INFUSION. MICROJET CASSETTES HAVE NOT BEEN SOLD/DISTRIBUTED BY SORENSON MEDICAL SINCE DEC. 31, 2005.

    Description of Event or Problem · 1

    SPOKE WITH THE WASHINGTON CO. CORONER OFFICE. SHE STATED THAT A DEATH OF A PATIENT OCCURRED IN 2006.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PCA MICROJET PUMP PCA MICROJET PUMP MEA SORENSON MEDICAL, INC. PCA MICROJET PUMP 310153

    Patients

    Seq Age Sex Outcome Treatment
    1