BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN 6000 CMS INFUSION PUMP

    MDR report key: 5770092 · Received July 5, 2016

    Report

    Report Number
    1722139-2016-00509
    Event Type
    Death
    Date Received
    July 5, 2016
    Date of Event
    June 1, 2016
    Report Date
    June 8, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVOLVED PUMP HAS NOT BEEN RETURNED TO MMDG, AND AN EVALUATION OF THE DEVICE HAS NOT BEEN POSSIBLE. MMDG WILL UPDATE THIS REPORT AS INFORMATION BECOMES AVAILABLE.

    Additional Manufacturer Narrative · 1

    (B)(4)'S CASE COMMENT FOR MW5062171: FOR THIS EVENT REPORT, MEDICAL HISTORY, CURRENT HEALTH STATUS, AND CAUSE OF DEATH ARE NOT REPORTED OTHER THAN "RESPIRATORY ISSUES". ADDITIONALLY, THE PATIENT WAS RECEIVING AN INFUSION OF (B)(4) JUST PRIOR TO THE PATIENT'S DEMISE. (B)(4) HAS BEEN REPORTED BY THE MANUFACTURER, WITH A "BLACK BOX WARNING", TO CAUSE SERIOUS INFUSION REACTIONS, INCLUDING DEATH, ESPECIALLY DURING THE INITIAL INFUSION. NO DETAILS WERE PROVIDED WHETHER OR NOT THE PATIENT WAS BEING MONITORED BY A MEDICAL PROFESSIONAL DURING THE INFUSION. ADDITIONALLY, NO PUMP SERIAL NUMBER, PUMP HISTORY, OR INFUSION PARAMETER SETTINGS WERE PROVIDED BY THE COMPLAINANT. THEREFORE, IT IS NOT POSSIBLE TO INFER OR ASSESS ANY RELATIONSHIP BETWEEN THE PATIENT'S DEATH AND USE OF THE CURLIN PUMP.

    Description of Event or Problem · 1

    MMDG RECEIVED A MEDWATCH LETTER STATING THAT A PATIENT HAD EXPIRED. THE LETTERS STATES THAT THE VISITING NURSE CONFIRMED THE PATIENT WAS STABLE PRIOR TO LEAVING AND THAT ON AN UNKNOWN DATE THE PHARMACY WAS INFORMED THE PATIENT HAD EXPIRED DUE TO RESPIRATORY ISSUES. MMDG WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION OR ATTEMPT ANY FOLLOW UP AS THE PHARMACY OR CAREGIVER INFORMATION WAS NOT PROVIDED IN THE MEDWATCH. [(B)(4)]

    Description of Event or Problem · 1

    (B)(4) RECEIVED A MEDWATCH LETTER STATING THAT A PATIENT HAD EXPIRED. THE LETTERS STATES THAT THE VISITING NURSE CONFIRMED THE PATIENT WAS STABLE PRIOR TO LEAVING AND THAT ON AN UNKNOWN DATE THE PHARMACY WAS INFORMED THE PATIENT HAD EXPIRED DUE TO RESPIRATORY ISSUES. (B)(4) WAS NOT ABLE TO OBTAIN ANY ADDITIONAL INFORMATION OR ATTEMPT ANY FOLLOW UP AS THE PHARMACY OR CAREGIVER INFORMATION WAS NOT PROVIDED IN THE MEDWATCH. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    422355 CURLIN 6000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 360-1400 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 Death BENEDRYL