BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PC UNIT

    MDR report key: 3110472 · Received April 18, 2013

    Report

    Report Number
    2016493-2013-00194
    Event Type
    Injury
    Date Received
    April 18, 2013
    Date of Event
    February 14, 2013
    Report Date
    February 26, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K051641
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO PRODUCT RETURN IS EXPECTED AND NO PATIENT FAILURE IS BELIEVED TO HAVE OCCURRED; THE CUSTOMER'S DESCRIPTION IS CONSIDERED TO BE NORMAL DEVICE FUNCTION. THIS FUNCTION ALLOWS ACTUAL PATIENT WEIGHT DIFFERENCES, EG. TOTAL BODY WEIGHT, LEAN BODY WEIGHT, ETC. TO BE USED ON THE SAME SYSTEM. THIS IS A SAFETY ELEMENT WHICH PREVENTS AUTOMATIC DOSE OR RATE CHANGES FROM OCCURRING IN ONE INFUSION WHEN A DIFFERENT INFUSION IS STARTED WITH A DIFFERENT WEIGHT. THE DEVICE IS DESIGNED TO MAIN PREVIOUS INFUSION PARAMETERS FOR 8 HOURS WHEN POWERED OFF. IT IS RECOMMENDED THAT WHEN THE USER IS FINISHED WITH ONE PATIENT, BEFORE PROGRAMMING FOR A NEW PATIENT, FOR THE DEVICE TO BE POWER CYCLED AND "NEW PATIENT" SELECTED TO PREVENT INADVERTENT PROGRAMMING.

    Description of Event or Problem · 1

    AN ANESTHESIOLOGIST INITIALLY CONTACTED CAREFUSION STATING THAT HE RECENTLY DISCOVERED IT IS POSSIBLE TO HAVE A SINGLE PCU WITH MULTIPLE MODULES ATTACHED, EACH MODEL WITH DIFFERENT WEIGHTS. THE PHYSICAN BELIEVED IT TO BE A SAFETY ISSUE BECAUSE THEIR DEVICES ARE NOT POWERED DOWN BETWEEN CASES IN ORDER TO SELECT NEW PATIENT, SO WEIGHTS FROM A PREVIOUS PATIENT REMAIN UNTIL THEY CHANGE THEM. A COPY OF CUSTOMER'S MEDWATCH WAS RECEIVED. THE TEXT STATES THE DEVICE WAS LEFT IN THE OPERATING ROOM AFTER A CASE AND NOT TURNED OFF. FOLLOWING THIS IT WAS PRE-PROGRAMMED FOR ANOTHER CASE, AND THE USER "DID NOT USE A PEDIATRIC WEIGHT BASED MODE" ALTHOUGH IT WAS AVAILABLE. THE PROGRAMMING RESULTED IN A RATE OF 10.8 ML/HR FOR THE MEDICATION, AND THE DEVICE WAS THEN PAUSED FOR SEVERAL HOURS UNTIL "...THE SYRINGE PUMP WAS TAKEN OFF OF PAUSE AND BEGAN IT'S INFUSION OF MEDICATION A BASED ON THE INCORRECT...WEIGHT. AT 13:26 THE USER NOTICES THAT THE SYRINGE PUMP HAS INFUSED MEDICATION A TOO RAPIDLY AND STOPS THE SYRINGE PUMP INFUSION, STABILIZES THE PATIENT AND REPORTS THE PROBLEM." THE CUSTOMER PREFERS THAT THE DEVICE DISALLOW DIFFERENT WEIGHTS BETWEEN MODULES. MULTIPLE PRODUCT IMPROVEMENTS WERE SUGGESTED BY THE CUSTOMER. THERE WAS UNSPECIFIED MEDICAL INTERVENTION TO STABILIZE THE PATIENT. ALTHOUGH REQUESTED, NO FURTHER PATIENT OR EVENT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    168408 ALARIS PC UNIT FRN CAREFUSION CORP. 8015 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS SYRINGE MODULE ADMINISTRATION SET| MODEL/LOT # UNK| ALARIS SYRINGE MODULE, SN UNK| ALARIS MODULE, MODEL AND SN UNK