BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    EXCELSIOR SYRINGE PUMP (ESP)

    MDR report key: 1419733 · Received April 17, 2009

    Report

    Report Number
    2027791-2009-00002
    Event Type
    Malfunction
    Date Received
    April 17, 2009
    Date of Event
    March 23, 2009
    Report Date
    April 17, 2009
    Manufacturer
    EXCELSIOR MEDICAL CORP.
    Product Code
    FRN
    PMA / PMN Number
    K914988
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL LOT NUMBER: 018650. AS OF 04/16/2009, THE CUSTOMER STATED THAT HE WOULD BE RETURNING BOTH PUMPS TO EXCELSIOR FOR INSPECTION. UPON ARRIVAL, THE PUMPS WILL BE EXAMINED IN ORDER TO CONFIRM THE REPORTED FAILURE AND DETERMINE THE ROOT CAUSE OF THE ISSUE. MANUFACTURE DATES FOR THE PUMPS ARE AS FOLLOWS: 018549 - 05/07/2008, 018650 - 08/20/2008. THIS MDR IS BEING FILED PRIOR TO RECEIPT OF THE AFOREMENTIONED PUMPS. EXCELSIOR MEDICAL WILL PROVIDE A FOLLOW-UP REPORT AS SOON AS MORE INFORMATION BECOMES AVAILABLE.

    Description of Event or Problem · 1

    CUSTOMER CALLED EXCELSIOR MEDICAL AND REPORTED TWO OUT OF BOX FAILURES ON NEW EXCELSIOR SYRINGE PUMPS (ESPS). THE CUSTOMER STATED THAT THE PUMPS ARE NOT ALARMING WHEN THE SYRINGE IS EMPTY. ONE FAILED TO ALARM DURING TESTING AND THE OTHER FAILED TO ALARM WHILE ON A PATIENT. CONCERNING THE PUMP THAT WAS ON THE PATIENT DURING THE FAILURE, THE CUSTOMER NOTED THAT THE SOLUTION HAD FINISHED INFUSING AND THE PUMP CONTINUED TO TRY TO INFUSE WITHOUT GIVING AN ALARM. THE CUSTOMER THEN ATTEMPTED TO TRIGGER THE ALARM BY PURPOSELY CAUSING AN OCCLUSION, HOWEVER, THE ALARM FAILED TO ACTIVATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXCELSIOR SYRINGE PUMP (ESP) ESP FRN EXCELSIOR MEDICAL CORP. ESP60 018549

    Patients

    Seq Age Sex Outcome Treatment
    1