BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ADAP-2000

    MDR report key: 1522119 · Received October 26, 2009

    Report

    Report Number
    1522119
    Event Type
    Malfunction
    Date Received
    October 26, 2009
    Date of Event
    October 23, 2009
    Report Date
    October 26, 2009
    Manufacturer
    REMINGTON MEDICAL, INC.
    Product Code
    DSA
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    RI, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    DURING TEMPORARY PACING WITH THE REMINGTON MEDICAL DISPOSABLE ADAPTER, ADAP-2000 AND A COMPATIBLE TEMPORARY PACER BOX, THE PATIENT INTERMITTENTLY DEVELOPED A LOSS OF CAPTURE DESPITE MAXIMUM OUTPUT AND CONFIRMATION BY X-RAY OF PROPER PACING WIRE PLACEMENT. ALSO, THE PACING ADAPTER DID NOT FIT INTO PACEMAKER WELL AND HAD TO BE FORCIBLY REMOVED FROM THE HEAD OF THE PACER AT THE END OF THE CASE. IT SEEMED TO BE STUCK IN PLACE. THIS PROBLEM WAS FOUND VERY QUICKLY. THE PATIENT'S PERMANENT PACEMAKER WAS REATTACHED AND THE PATIENT HAD A GOOD OUTCOME. THE TEMPORARY PACER BOX WAS TESTED AND WAS NOT PART OF THE PROBLEM. WE HAVE NEVER HAD PROBLEMS WITH THIS ADAPTER BEFORE BUT THIS IS ONE OF TWO REPORTS WHICH OCCURRED ON THE SAME DAY. THERE SEEMS TO BE A PROBLEM WITH THIS LOT. WE HAVE REMOVED ALL ADAPTERS WITH THIS LOT IN OUR HOSPITAL SYSTEM. MANUFACTURER'S RESPONSE (PER REPORTER):THEY HAVE RECEIVED COMPLAINTS ABOUT THE ADAPTER NOT FITTING WELL. THERE IS DEFINITELY A PROBLEM WITH THIS LOT. OUR FACILITY'S COMPLAINTS WERE THE FIRST COMPLAINT ABOUT A PATIENT BEING AFFECTED DUE TO THIS. WE HAVE PULLED ALL ADAPTERS WITH THIS LOT NUMBER IN OUR HOSPITAL SYSTEM.

    Description of Event or Problem · 1

    DURING TEMPORARY PACING WITH THE REMINGTON MEDICAL DISPOSABLE ADAPTER, ADAP-2000 AND A COMPATIBLE TEMPORARY PACER BOX, THE PATIENT INTERMITTENTLY DEVELOPED A LOSS OF CAPTURE DESPITE MAXIMUM OUTPUT AND CONFIRMATION BY X-RAY OF PROPER PACING WIRE PLACEMENT. ALSO, THE PACING ADAPTER DID NOT FIT INTO PACEMAKER WELL AND HAD TO BE FORCIBLY REMOVED FROM THE HEAD OF THE PACER AT THE END OF THE CASE. IT SEEMED TO BE STUCK IN PLACE. THIS PROBLEM WAS FOUND VERY QUICKLY. THE PATIENT'S PERMANENT PACEMAKER WAS REATTACHED AND THE PATIENT HAD A GOOD OUTCOME. THE TEMPORARY PACER BOX WAS TESTED AND WAS NOT PART OF THE PROBLEM. WE HAVE NEVER HAD PROBLEMS WITH THIS ADAPTER BEFORE BUT THIS IS ONE OF TWO REPORTS WHICH OCCURRED ON THE SAME DAY. THERE SEEMS TO BE A PROBLEM WITH THIS LOT. WE HAVE REMOVED ALL ADAPTERS WITH THIS LOT IN OUR HOSPITAL SYSTEM. MANUFACTURER'S RESPONSE (PER REPORTER):THEY HAVE RECEIVED COMPLAINTS ABOUT THE ADAPTER NOT FITTING WELL. THERE IS DEFINITELY A PROBLEM WITH THIS LOT. OUR FACILITY'S COMPLAINTS WERE THE FIRST COMPLAINT ABOUT A PATIENT BEING AFFECTED DUE TO THIS. WE HAVE PULLED ALL ADAPTERS WITH THIS LOT NUMBER IN OUR HOSPITAL SYSTEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ADAP-2000 CABLE, TEMPORARY PACING, DISPOSABLE DSA REMINGTON MEDICAL, INC. * 090274

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR