BEUDAMED
    FDA Adverse Event Death Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 2870660 · Received November 16, 2012

    Report

    Report Number
    1722139-2012-01160
    Event Type
    Death
    Date Received
    November 16, 2012
    Date of Event
    March 1, 2012
    Report Date
    October 18, 2012
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    RECEIVED MEDWATCH # MW5027417 ON 11/20/2012.

    Additional Manufacturer Narrative · 1

    DEVICE WAS NOT RETURNED.

    Description of Event or Problem · 1

    PT'S WIFE COMPLAINS: DUE TO LACK OF TRAINING, SHE COULD NOT BE REMEDIATED IN A TIMELY MANNER WHEN PUMP ALARMED. PT WAS DIAGNOSED WITH SEPTICEMIA IN THE HOSPITAL ON (B)(6) 2012 AND WAS DISCHARGED ON (B)(6) 2012. (B)(6) PROVIDED A 4000 CMS PUMP WITH THE MED, SET IT UP, GAVE TWO MINUTES INSTRUCTION TO PT, NOT WIFE. PUMP ALARMED ON FIRST NIGHT; 24 HOURS (B)(6) HOTLINE TOLD WIFE TO CHANGE THE BATTERY. OVER NEXT FOUR DAYS, PUMP ALARMED UP OR DOWN OCCLUSION IN EVERY FOUR TO SIX HOURS. HOTLINE INSTRUCTED WIFE TO MESSAGE TUBING TO REMOVE AIR. WIFE REQUESTED A USER MANUAL AND RECEIVED A PRINTED COPY. ON (B)(6), PT TURNED OFF PUMP TO NOT DISTURB THE CONGREGATION IN CHURCH AND FORGOT TO TURN BACK ON UNTIL (B)(6). WIFE SAID NO ONE HAD TAUGHT HER TO RECOGNIZE SIGNS AND SYMPTOMS OF DEHYDRATION AND DISORIENTATION. A NURSE CAME OUT TO SEE PT AND NOTED THAT PT HAD RETAINED 20-30 POUNDS OF WATER IN HIS LEGS AND HAD TO RE-ADMIT TO HOSPITAL. PHYSICIAN TOLD WIFE HIS DISORIENTATION WAS DUE TO TOO MANY TOXINS IN HIS BLOOD STREAM DUE TO KIDNEY FAILURE. PT WAS IN HOSPITAL FOR 5-6 DAYS THEN RELEASED TO HOSPICE WITH DIAGNOSIS OF KIDNEY AND LIVER DAMAGE AND LIVER CANCER. ON THE FIRST DAY OF DISCHARGE, THE PICC LINE CAUSED THE PT TO BLEED FROM THE CONNECTION. WIFE CLAMPED THE LINE AND A NURSE CAME OUT TO REBUILD THE PICC LINE CONNECTION. PUMP THEN RECONNECTED AFTER 4-6 HOURS OFF OF PT. THE PT EXPIRED FOUR DAYS LATER. WIFE SAID SHE WAS UNAWARE OF CURLIN'S HOTLINE NUMBER AND HAD NEVER CALLED THE MFR. SHE STATED HER HUSBAND WAS ON THE MEDICATION FOR SIX WEEKS AND REFERRED TO THE MEDICATION AS LIFE SUSTAINING. INFORMED THAT THE MEDICATION WAS AN ANTIBIOTIC AND NOT CONSIDERED LIFE SUSTAINING. INSTRUCTED HOW THE MEDICATION WAS DELIVERED, I. E., VIA INTERMITTENT DELIVERY AND NOT A CONTINUOUS ADMINISTRATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    72112 CURLIN INFUSION 4000CMS IV PUMP FRN MOOG MEDICAL DEVICES GROUP 4000CMS

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Male OXACILLIN 2 GM