BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN 4000 CMS INFUSION PUMP

    MDR report key: 5475770 · Received March 2, 2016

    Report

    Report Number
    1722139-2016-00146
    Event Type
    Death
    Date Received
    March 2, 2016
    Date of Event
    January 22, 2016
    Report Date
    February 1, 2016
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    TWO PUMPS HAD BEEN PROVIDED TO THE PATIENT, WITH THE SERIAL NUMBERS (B)(4). THIS REPORT IS REGARDING PUMP (B)(4). A REPORT HAS ALSO BEEN FILED FOR PUMP (B)(4) (1722139-2016-00147). A REVIEW OF THE TWO PUMPS' INTERNAL EVENT LOGS TELLS THE FOLLOWING STORY: BOTH PUMPS HAD A TREATMENT PROGRAMMED ON (B)(6) 2015, AND WERE PROVIDED TO THE PATIENT. THE PATIENT RECEIVED INFUSIONS FROM PUMP (B)(4) UNTIL MID-DAY ON (B)(6), AT WHICH TIME THE DEVICE WAS STOPPED BY THE USER. THE PATIENT THEN RECEIVED A CONTINUOUS INFUSION FROM PUMP (B)(4) FROM 1:02 PM ON (B)(6) UNTIL THE DEVICE WAS STOPPED BY THE USER AT 1:00 PM ON (B)(6). ALL INFUSIONS APPEAR TO HAVE BEEN DELIVERED AS PROGRAMMED. NO ERRORS OR ALARMS WERE RECORDED IN EITHER OF THE PUMPS' INTERNAL EVENT LOGS. BOTH DEVICES WERE ALSO WERE SUBJECTED BY (B)(4) TO A VISUAL INSPECTION AND A NUMBER OF FLOW AND VOLUMETRIC ACCURACY TESTS. PUMP (B)(4) DID NOT SHOW ANY VISIBLE DAMAGE, WHILE PUMP (B)(4) SHOWED A SMALL HAIRLINE CRACK THAT IS COSMETIC IN NATURE AND DOES NOT AFFECT THE PERFORMANCE OF THE DEVICE. BOTH DEVICES PERFORMED WITHIN (B)(4) NON-REPORTABILITY TOLERANCES DURING THE FLOW AND VOLUMETRIC ACCURACY TESTING. BASED ON THE ABOVE-LISTED EVALUATION RESULTS AND DATA LOG REVIEW, (B)(4) HAS CONCLUDED THAT BOTH DEVICES PERFORMED ACCORDING TO SPECIFICATIONS.

    Description of Event or Problem · 1

    THE INITIAL REPORTER STATED: "PATIENT EXPIRED WHILE RECEIVING INOTROPIC THERAPY ON THE PUMP. THE PATIENT HAD TWO PUMPS IN THEIR POSSESSION..PATIENT'S WIFE CALLED OPTIONCARE TO LET US THEM KNOW THAT PATIENT HAD PASSED AWAY UNEXPECTEDLY ON FRIDAY (B)(6) 2016." THE CALLER REQUESTED (B)(4) TO RECEIVED THE PUMPS AND PULL THE PUMP HISTORY TO RULE OUT IF THE PUMPS MAY HAVE CONTRIBUTED TO THE PATIENT'S DEMISE. THEY ALSO REQUESTED THAT (B)(4) INSPECT THE PUMP TO MAKE SURE THE PUMP WAS INFUSING WITHIN THE PROPER SPECIFICATIONS. (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    129950 CURLIN 4000 CMS INFUSION PUMP INFUSION PUMP FRN MOOG MEDICAL DEVICES GROUP 350-1100 N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 44 YR Death MILRINONE