BEUDAMED
    FDA Adverse Event Death Summary report: N

    CADD

    MDR report key: 10619799 · Received October 2, 2020

    Report

    Report Number
    3012307300-2020-10054
    Event Type
    Death
    Date Received
    October 2, 2020
    Date of Event
    September 15, 2020
    Report Date
    January 20, 2021
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NO
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: DEVICE EVALUATION: ONE SMITHS MEDICAL CADD-LEGACY PCA PUMP MODEL 6300 WAS RETURNED FOR ANALYSIS IN USED CONDITION. REVIEW OF THE DEVICE'S EVENT HISTORY LOG (EHL) FOUND THAT DURING INITIAL SET UP FOR THIS PATIENT ON (B)(6) 2020 THE DEMAND DOSE (BOLUS) WAS SET AT 4 ML NOT 1 ML AS REPORTED. PER THE EHL AT 2:26 AM ON (B)(6) 2020 THE DEMAND DOSE (BOLUS) WAS THEN CHANGED FROM 4 ML TO 1 ML AFTER THE BOLUS HAD BEEN INTERRUPTED AT 2:15 AM. AFTER CHANGING THE BOLUS, THE PUMP WAS PUT BACK INTO NORMAL OPERATION MODE AT 2:27 AM. THE PUMP RAN UNTIL 3:43 AM WHEN IT PRODUCED A HIGH-PRESSURE ALARM. AT 3:52 THE HIGH-PRESSURE ALARM WAS CANCELED, THE DISPOSABLE WAS REMOVED FROM THE DEVICE, THE PUMP WAS TURNED OFF, AND THE PUMP POWERED DOWN. BASED ON THE INFORMATION PROVIDED BY THE PUMPS EHL, THE INVESTIGATION DETERMINED THAT NO ISSUES WITH THE PUMPS FUNCTIONALITY OCCURRED DURING THE REPORTED INCIDENT.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H2: SEE B5.

    Additional Manufacturer Narrative · 0

    OTHER, OTHER TEXT: H2: SEE B5.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE DOCTOR INDICATING THAT THE TREATMENT WITH THE CADD LEGACY PUMP MADE AN OVER DOSE POSSIBLE, BUT IT WAS NOT THE PUMP ITSELF THAT CONTRIBUTED TO THE PATIENT'S DEATH. THE ISSUE OCCURRED AT MO I RANA HOSPITAL.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE DOCTOR INDICATING THAT THE TREATMENT WITH THE CADD LEGACY PUMP MADE AN OVER DOSE POSSIBLE, BUT IT WAS NOT THE PUMP ITSELF THAT CONTRIBUTED TO THE PATIENT'S DEATH. THE ISSUE OCCURRED AT MO I RANA HOSPITAL.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED INDICATING THAT A PATIENT WITH TERMINAL CANCER WAS RECEIVING VALIUM AND MORPHINE VIA A SMITHS MEDICAL CADD LEGACY PUMP SUBCUTANEOUSLY. THE REPORTER INDICATED THAT THE NURSE WAS REPORTED TO BE ADMINISTERING A BOLUS OF MEDICATION, BUT THE PUMP WAS REPORTED TO HAVE GIVEN MORE BOLUS THAN WHAT WAS SET. IT WAS ALSO REPORTED THAT THE NURSE THEN HAD TO STOP THE PUMP FROM INFUSING. THE REPORTER ALSO INDICATED THAT THE PUMP SETTINGS WERE REPORTED TO HAVE BEEN CHECKED, NOTING THAT 2 BOLUS DOSES HAD BEEN GIVEN INSTEAD OF ONE. OTHER RELEVANT HISTORY WAS ALSO REPORTED, PATIENT HAD SMALL BOWEL NEUROENDOCRINE TUMOR (NET) WITH LIVER METASTASIS AND HEART IMPACT FROM 2005 AND HAD OTHER MEDICAL TREATMENT MEDICATIONS: PARACETAMOL 1G X 4, HALOPERIDOL 1 MG X1, FUROSEMID 40 MG X1, METHYLPREDNISLOLON 4 MG X2. SUBSEQUENTLY, THE PATIENT WAS REPORTED TO EXPIRE. THE AVAILABLE INFORMATION STATES THAT 'THE PATIENT DIED, BUT DUE TO DIFFERENT CIRCUMSTANCES, THE HOSPITAL SAYS THAT THEY CANNOT BE 100% SURE WHAT CAUSED THE DEATH. BUT THE PUMP RESPONDED ABNORMAL WHEN BOLUS DOSE WAS GIVEN.'

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1087146 CADD PUMP, INFUSION FRN 6300

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Death