BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2782124 · Received October 3, 2012

    Report

    Report Number
    2016493-2012-00419
    Event Type
    Injury
    Date Received
    October 3, 2012
    Date of Event
    August 31, 2012
    Report Date
    September 6, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER'S REPORT OF A POSSIBLE OVER INFUSION OF HEPARIN COULD NOT BE VERIFIED. THE LOG REVIEW CONDUCTED SHOWED THAT ON THE EVENT DATE AN INFUSION OF HEPARIN WAS STARTED AT 7:49 PM AND THEN TERMINATED BY THE USER AT 10:00 PM PRIOR TO THE PROGRAM COMPLETION. THE ALARM THAT PRECEDED THE TERMINATION WAS NOT AN AIR-IN-LINE ALARM AS REPORTED, BUT A PATIENT-SIDE OCCLUSION ALARM. THERE WAS NO INDICATION (DOOR OPEN OR FLO-STOP OPEN ALERT) THAT THE TUBING WAS DISCONNECTED TO FLUSH OUT AIR. AT 10:00PM THE PUMP WAS REPLACED WITH ANOTHER PUMP MODULE AND THE HEPARIN INFUSION WAS RESTARTED. THIS INFUSION RAN FOR ABOUT ONE HOUR WHEN AT 11:08 PM WHEN THE PUMP ALARMED FOR AN AIR-IN-LINE CONDITION. THE DEVICE WAS REMOVED AND THEN REATTACHED AND THE PROGRAMMING WAS STARTED AGAIN. THIS INFUSION RAN FOR ANOTHER HOUR UNTIL 12:19 AM ON (B)(6) 2012 WHEN THE USER TERMINATED THE PROGRAM. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE COULD NOT BE DETERMINED FROM THE LOG REVIEW. (B)(4).

    Description of Event or Problem · 1

    BIOMED REPORTED THAT A PATIENT IN THE BURN UNIT RECEIVED AN OVER INFUSION OF HEPARIN AND IS REQUESTING AN EVENT LOG REVIEW TO SEE IF IT WAS A PROGRAMMING ERROR OR A DEVICE ERROR. THE NURSE REPORTED THAT ON (B)(6) 2012 AT 1930, SHE PRIMED AN IV SET AND HUNG A NEW BAG OF HEPARIN SET TO RUN AT 43.2 ML PER HOUR. THE PUMP SETTINGS WERE VERIFIED BY ANOTHER RN. SHE STATED THAT AT 2130 THE PUMP ALARMED FOR AIR-IN-LINE. AT THAT TIME, SHE DISCONNECTED THE TUBING FROM THE PATIENT AND RE-PRIMED THE TUBING TO REMOVE THE AIR. THE PUMP WAS RESTARTED AT THE SAME RATE. AROUND 2330 SHE NOTICED THE HEPARIN BAG HAD ALMOST COMPLETELY INFUSED. SHE HAD THE CHARGE NURSE COME IN AND VERIFY THE CORRECT SETTINGS AND SET UP. THE CHARGE NURSE VERIFIED THE PUMP SETTINGS AND THE REPORTED AMOUNT INFUSED WAS 312 ML. THE NURSE REPLACED THE PUMP AND THE INFUSION RAN CORRECTLY. NURSE COULD NOT CONFIRM VOLUME OF HEPARIN BAG BUT BELIEVED IT WAS A 500 CC VOLUME BAG. NURSE THAT STATED THE PATIENT HAD NOSE BLEEDS FOR 4 HOURS AND REQUIRED EXTRA BLOOD DRAWS AND HEMODYNAMIC MONITORING. THE NURSE REPORTED THAT THE BLEEDING MAY HAVE BEEN A RESULT OF AN OVER INFUSION OF HEPARIN. THE PATIENT'S PITT WAS REPORTED TO BE GREATER THAN 200. BIOMED TESTED THE UNIT AND STATED THAT IT FAILED THE RATE CAL CHECK LOW WITH 11.4 ML INFUSED WHEN SET TO 12 ML AND THAT ALL OTHER TESTS PASSED ON THE LVP AND PCU. CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP. 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULE: SN (B)(4)| THERAPY DATE:| THERAPY DATE:| ALARIS PUMP MODULE, SN (B)(4)| THERAPY DATE:| THERAPY DATE:| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK| ALARIS PC UNIT, SN (B)(4)