BEUDAMED
    FDA Adverse Event Injury Summary report: N

    GEMINI PCI INFUSION PUMP

    MDR report key: 3251786 · Received July 17, 2013

    Report

    Report Number
    2016493-2013-00304
    Event Type
    Injury
    Date Received
    July 17, 2013
    Date of Event
    January 2, 2013
    Report Date
    February 14, 2013
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K880479
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). BOTH PUMPS WERE RECEIVED FOR INVESTIGATION. A VISUAL INSPECTION IDENTIFIED THAT THE DOOR SEARS WERE MISSING ON DEVICE 1 AND ON DEVICE 2 CHANNEL A. THEY WERE PRESENT BUT DAMAGED ON DEVICE 2 CHANNEL B. AS A RESULT OF THIS, ALL THE THREE CHANNELS WERE FOUND NOT TO BE OPERATING AS INTENDED. DURING TESTING, THEY FAILED TO CLAMP THE ADMIN SET UPON DOOR OPENING. RATE ACCURACY TESTING WAS PERFORMED IN CONTROLLED CONDITIONS AND RESULTS SHOWED CORRECT OPERATION OF THE SYSTEM BOTH FOR DEVICE 1 AND FOR DEVICE 2 CHANNEL A. IT WAS NOT POSSIBLE TO TEST CHANNEL B DUE TO AN ERROR MESSAGE INDICATING A MISSING MOTOR SYNCHRONISATION SIGNALS; THE ERROR DOES NOT APPEAR TO BE RELATED TO THE REPORTED ISSUE. ALTHOUGH IT IS NOT POSSIBLE TO DETERMINE DEFINITIVELY FROM THE INVESTIGATION, IT IS LIKELY THAT CONSIDERING THE SEARS DAMAGE HIGHLIGHTED ABOVE) THE SAFETY CLAMP WAS NOT AUTOMATICALLY PUT IN THE CLOSED POSITION WHEN THE ADMIN SET WAS REMOVED FROM THE DEVICE. IF THE ROLLER CLAMP HAD NOT BEEN CLOSED (AS CONFIRMED BY THE CUSTOMER), THIS MAY HAVE RESULTED IN AN UNCONTROLLED FLOW CONDITION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A PT WAS TRANSFERRED FROM THE CATH LAB TO ICU WITH A MORPHINE AND MIDAZOLAM INFUSION (100 MGS IN 100 MLS NORMAL SALINE) RUNNING AT 4 MGS/HR. THE INFUSION WAS INITIALLY STARTED IN ED AT 2 MGS/HR. ON ARRIVAL TO THE ICU, THE STAFF REMOVED THE INFUSION SET ADMINISTERING MORPHINE/MIDAZOLAM FROM THE PUMP AS THEY NEEDED THEIR PUMP BACK. WHEN THE ICU STAFF RETURNED WITH A NEW PUMP, THEY NOTED THAT THE INFUSION BAG THAT WAS PREVIOUSLY 3/4 FULL ON ARRIVAL WAS NOW EMPTY. THE CLINICIAN STATED THAT "DESIGN OF GIVING SET IS SUCH THAT WHEN IT IS REMOVED FROM (B)(4), IT IS IN THE OCCLUDED POSITION; HOWEVER, IT IS ROUTINE PRACTICE TO ENSURE ROLLER CLAMP IS ALSO OCCLUDED. IN THE RUSH TO CHANGE EQUIPMENT OVER, THIS WAS MISSED. INFUSION RAN THROUGH WITH PT RECEIVING APPROX 50 MG MORPHINE AND 50 MG MIDAZOLAM. PT BECAME MORE HYPOTENSIVE AND REQUIRED ARAMINE BOLUS AND COMMENCED ADRENALINE INFUSION. ADRENALINE INFUSION REQUIRED FOR 4 HOURS POST INCIDENT AND THEN CEASED. DUE TO PT'S PRESENTING CLINICAL CONDITION, SEDATION AND INOTROPIC SUPPORT WAS REQUIRED AS ROUTINE MANAGEMENT." THE ABOVE INFO WAS FIRST REPORTED AGAINST THE ADMINISTRATION SET (PLEASE REFER TO MFR REPORT 9616066-2013-00086). ON (B)(6) 2013, THE LOCAL AFFILIATE FIRST MENTIONED TWO PUMPS WITH BROKEN SEAR. FURTHER CLARIFICATION WAS RECEIVED ON THE (B)(6) 2013 FROM THE LOCAL AFFILIATE TO ADVISE THAT THESE TWO PUMPS WERE IN QUARANTINED FOR REPAIR; HOWEVER, A NURSE FOUND ONE OF THEM AND USED IT. THEY WERE UNABLE TO CONFIRM WHICH OF THE TWO PUMPS WAS THE ONE INVOLVED IN THE INCIDENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332481 GEMINI PCI INFUSION PUMP FRN CAREFUSION CORPORATION 1311 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS GEMINI ADMIN SET: MODEL 2200-0500/LOT # UNK| ALARIS GEMINI PUMP: MODEL PC2, SN # (B)(4)