BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CURLIN INFUSION 4000CMS IV PUMP

    MDR report key: 1982272 · Received January 31, 2011

    Report

    Report Number
    1722139-2011-00009
    Event Type
    Injury
    Date Received
    January 31, 2011
    Date of Event
    December 28, 2010
    Report Date
    January 31, 2011
    Manufacturer
    MOOG MEDICAL DEVICES GROUP
    Product Code
    FRN
    PMA / PMN Number
    K981816
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: PERFORMANCE TESTS PERFORMED, ACCURACY AND ALARMS. THE PT HISTORY LOG WAS REVIEWED TO VERIFY THERAPY PARAMETERS AND CHECK FOR SIGNS OF UNDER INFUSION. RESULTS: KEYPAD ON/OFF KEY FOUND TO BE WORN OUT. THIS MEANS IT WAS FLAT OR DEPRESSED AND INTERMITTENTLY MAKING A CONNECTION AND ACTUATING THE ON/OFF KEY. THIS WAS EVIDENCED BY THE PATIENT HISTORY LOG. CONCLUSION: KEYPAD ON/OFF KEY BEING WORN OUT DIRECTLY CAUSED THE PUMP TO SHUT DOWN AND TURN ON MULTIPLE TIMES. THE PUMP DID NOT UNDER INFUSE, IT SIMPLY TURNED ITSELF OFF. THIS CAUSED A DELAY IN THERAPY UNTIL THE PT COULD RETURN TO THE INFUSION CENTER AND FINISH THE THERAPY WITH ANOTHER DEVICE.

    Description of Event or Problem · 1

    COMPLAINT DESCRIPTION: "PUMP HAS UNDER-DELIVERED BY HALF THE DOSE MULTIPLE TIMES." (B)(6) CLINICIAN CONTACTED REPORTER AND STATED THE FOLLOWING: "THE PT WAS SENT HOME ON THE PUMP FROM THE OUTPATIENT INFUSION AT THE HOSPITAL AND HAD TO RETURN TO THE INFUSION CENTER, 2 SEPARATE OCCASIONS DUE TO UNDER INFUSION. ON THE 3RD RETURN, THEY KEPT THE PT AT THE CENTER TO FINISH THE INFUSION ON A BAXTER PUMP. THE BIOMED STATED THEY DID NOT DO ANY TESTING ON THE PUMP." THE INFUSION CENTER NURSE WAS CONTACTED AS WELL AND STATED "THE PT CAME IN ON TUESDAY. THEY SENT HER HOME WITH PUMP INFUSING 5FU (FLUOROURACIL). THEY CONNECTED A 550ML BAG OF MEDICATION AND SET THE PUMP TO RUN AT 12ML/HR FOR 46 HOURS. THE PT WAS TO RETURN TO THE INFUSION CENTER ON THURSDAY TO HAVE THE PUMP DISCONTINUED. NURSE STATES THAT WHEN THE PT RETURNED ON THURSDAY, THE MEDICATION BAG HAD AT LEAST 1/2 OF THE MED STILL IN IT AND THE PUMP WAS OFF. PT DENIED TURNING THE PUMP OFF. BATTERIES WERE CHANGED. NURSE REPROGRAMMED THE PUMP TO RUN THE REMAINDER OF THE MED AND SENT THE PT HOME, TO RETURN ON FRIDAY. WHEN THE PT RETURNED ON FRIDAY AS INSTRUCTED, THE PUMP WAS OFF AND NONE OF THE MEDS HAD BEEN DELIVERED. THE PT AGAIN DENIED HAVING TURNED THE PUMP OFF. THE NURSE THEN KEPT THE PT AT THE INFUSION CENTER AND RAN THE REMAINDER OF THE MED AT THE INFUSION CENTER ON ANOTHER PUMP. SHE STATES THAT ALTHOUGH IT UNCONVINCED THE PT AND PROLONGED THE TREATMENT, THERE WAS NO INJURY. THEY DID NOT KEEP THE ADMIN SET AND KNOWS ONLY THAT IT WAS A STRAIGHT LINE UNFILTERED BAG SPIKE SET (INFUSION WAS FROM A BAG)."

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention