BEUDAMED
    FDA Adverse Event Death Summary report: N

    COLLEAGUE UNKNOWN

    MDR report key: 1714385 · Received June 9, 2010

    Report

    Report Number
    6000001-2010-00649
    Event Type
    Death
    Date Received
    June 9, 2010
    Date of Event
    May 5, 2010
    Report Date
    May 17, 2010
    Manufacturer
    BAXTER HEALTHCARE - SINGAPORE
    Product Code
    FRN
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). THE FOLLOWING IS A CLARIFICATION TO THE EVENT DESCRIPTION FROM THE INITIAL MEDWATCH REPORT. THIS INFORMATION IS BEING PROVIDED IN RESPONSE TO FEEDBACK RECEIVED FROM THE FDA DURING A PHONE CONVERSATION WITH BAXTER ON JUNE 18, 2010: THIS IS A REPORT OF A (B) (6) PATIENT WHO WAS RECEIVING MORPHINE SULPHATE VIA A COLLEAGUE DEVICE WHEN A NURSE IN A PALLIATIVE CARE UNIT ADMINISTERED A "BOLUS" OF MORPHINE, AND THE PATIENT PASSED AWAY 58 HOURS LATER. THE CUSTOMER DECLINED TO SEND THE PUMP BACK BECAUSE THIS WAS CONSIDERED A PROGRAMMING ERROR ON THE PART OF THE NURSE. ACCORDING TO THE INTERNAL INVESTIGATION CONDUCTED AT THE CUSTOMER SITE, THE DOSE ADMINISTERED IN ERROR WAS 47ML/HR WHILE THE PRESCRIBED DOSE WAS SUPPOSED TO BE 1ML/HR OF MORPHINE 60MILLIGRAMS AND VERSED (MIDAZOLAM). THE NURSE PROGRAMMED THE BOLUS OF 47ML/HR ON "SECONDARY" INFUSION RATHER THAN "PRIMARY" AND THIS WAS BYPASSED ON THE PUMP. IT IS UNKNOWN IF THIS ERROR WAS IN FACT THE CAUSE OF THE PATIENT'S DEMISE.

    Additional Manufacturer Narrative · 1

    (B) (4). SAMPLE AVAILABILITY AND CLINICAL DETAILS HAVE BEEN REQUESTED FROM THE CUSTOMER.

    Additional Manufacturer Narrative · 1

    (B) (4).THE FOLLOWING ADDITIONAL INFORMATION WAS OBTAINED FROM THE CUSTOMER: THE PUMP WILL NOT BE RETURNED FOR EVALUATION AS IT WAS A PROGRAMMING ERROR ON THE PART OF THE NURSE, AND NOT A PROBLEM WITH THE PUMP ITSELF. THE CUSTOMER WAS UNSURE OF THE EXACT AMOUNT TO BE INFUSED, BUT SHE KNEW IT WAS THE AMOUNT THAT WAS LEFT IN THE PIGGY BACK. SHE SAID THAT THE NURSE PROGRAMMED IT ON "SECONDARY" INFUSION RATHER THAN "PRIMARY" AND THIS WAS BYPASSED ON THE PUMP.

    Description of Event or Problem · 1

    STAFF NOTICED THE TIP OF THE ESSURE DEVICE WAS BENT AFTER OPENING THE PACKAGE BUT PRIOR TO USE.====================== HEALTH PROFESSIONAL'S IMPRESSION======================DEVICE IS DEFECTIVE.====================== MANUFACTURER RESPONSE FOR PERMANENT BIRTH CONTROL SYSTEM, ESSURE======================WILL REPLACE PRODUCT AND SEND RETURN KIT FOR EVALUATION.

    Description of Event or Problem · 1

    THE LAY USER/PATIENT CONTACTED LIFESCAN ALLEGING THE METER DOES NOT POWER ON. THE ISSUE WAS NOT RESOLVED WITH TROUBLESHOOTING. THERE WERE NO ALLEGATIONS OF HARM OR INJURY. REPLACEMENT PRODUCTS WERE SENT TO THE PATIENT.

    Description of Event or Problem · 1

    ON MAY 17 2010, A CUSTOMER REPORTED THAT THE COLLEAGUE VOLUMETRIC INFUSION PUMP, TYPE UNKNOWN, PRODUCT CODE UNK_PRD_00182, SN UNKNOWN, HAD AN ISSUE. THE CUSTOMER REPORTED THAT A NURSE IN A PALLIATIVE CARE UNIT ADMINISTERED A "BOLUS" OF MORPHINE BY USING THE PIGGY-BACK FUNCTIONALITY ON A COLLEAGUE PUMP ("RATE-VOLUME-START" MODE). RETURNING TO THE PRIMARY INFUSION MODE, SHE ACCIDENTLY ENTERED A RATE OF 47 ML/HOUR OF MORPHINE AND THE PATIENT EVENTUALLY DIED. THE PROCESS STEP IS DURING USE ON PATIENT, AND THE PATIENT DIED. AVAILABILITY OF THE DEVICE FOR EVALUATION IS UNKNOWN. INCIDENT DATE: (B) (6)-2010. BAXTER NOTIFICATION DATE: MAY-17-2010. PRODUCT SURVEILLANCE NOTIFICATION DATE: MAY-17-2010.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 COLLEAGUE UNKNOWN PUMP, INFUSION FRN BAXTER HEALTHCARE - SINGAPORE

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| H| R