BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS SYSTEM INFUSION PUMP

    MDR report key: 1033793 · Received April 24, 2008

    Report

    Report Number
    2016493-2008-00034
    Event Type
    Injury
    Date Received
    April 24, 2008
    Date of Event
    March 19, 2008
    Report Date
    March 31, 2008
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT INFORMATION REQUESTED AND ALL AVAILABLE INFORMATION IS INCLUDED.

    Description of Event or Problem · 1

    FACILITY REPORTED PEDIATRIC PATIENT HAD PREVIOUSLY BEEN PLAYING WITH HIS IV PUMP, SO HAD A SITTER ASSIGNED. PATIENT OPENED THE PUMP DOOR AND BROKE OFF BOTH SEARS. STATES THERE WAS FREE FLOW FOR A FEW MINUTES BEFORE IT WAS NOTICED. INFUSION OF HEPARIN 25, 000U/250 ML WAS HUNG AT 4 AM TO INFUSE AT 150U/KG/DAY, OR 1860 U/DAY. EVENT REPORTED TO PHARMACIST AROUND 10:30 AM, BUT STAFF UNSURE EXACTLY WHEN EVENT OCCURRED; STAT PTT AND PT DONE TO CHECK PATIENT'S CONDITION AND TRY TO ASCERTAIN HOW MUCH INFUSED. PTT WAS OVER 200 AND PT OVER 100. GAVE PROTAMINE 45 MG OVER 1 HOUR AND REPEAT PTT WAS 38.3, PT WAS 14.5. NO EVIDENCE OF BLEEDING OR OTHER ADVERSE OUTCOME. UNSURE IF DEVICE ALARMED. BIOMED TESTED DEVICE AND STATED IT ALARMED AS EXPECTED AS SOON AS THE DOOR WAS OPENED. PATIENT HAS HAD TRANSPLANT AS PLANNED AND HAD NO LONG TERM ADVERSE EFFECT RELATED TO THE OVERINFUSION. EVENT LOGS AND DEVICE REQUESTED MULTIPLE TIMES, BUT BIOMED STATES HE KNOWS THE CHILD BROKE THE SEARS AND DOES NOT SEE ANY BENEFIT TO SENDING DEVICE FOR FURTHER EVALUATION BY CARDINAL HEALTH. FOLLOW-UP REPORT WILL BE FILED IF DEVICE IS RECEIVED IN THE FUTURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS SYSTEM INFUSION PUMP FRN INFUSION PUMP FRN CARDINAL HEALTH ALARIS PRODUCTS 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 2 YR Required Intervention