BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PCA MODULE

    MDR report key: 1984543 · Received February 2, 2011

    Report

    Report Number
    2016493-2011-00209
    Event Type
    Injury
    Date Received
    February 2, 2011
    Date of Event
    September 14, 2010
    Report Date
    September 28, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    MEA
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: 02/02/2011. (B)(4). THE PRODUCT WAS EVALUATED FOR THE REPORTED UNDERINFUSION OF OPIOID AND WAS CONFIRMED AND REPLICATED DURING TESTING. DATA FROM THE PCA LOG INDICATES THAT THE DEVICE WAS FIRST PROGRAMMED AROUND 7:15 PM ON (B)(6) 2010 TO INFUSE A TERUMO 30ML SYRINGE CONTAINING APPROX 22.34 MLS. OVER THE NEXT 13 HRS 22 PCA DOSES WERE LOGGED AS BEING DELIVERED FOR A TOTAL OF 22 ML BEFORE BEING TURNED OFF. REMAINING VOLUME IN THE SYRINGE AT THE END OF THE INFUSION WAS LOGGED AS 0.34 ML HOWEVER, ACCORDING TO THE CUSTOMER THE SYRINGE WAS FULL. TESTING ON THE DEVICE REPLICATED THE FAILURE MODE USING THE PARAMETERS AND SYRINGE TYPE IDENTIFIED IN THE LOG REVIEW TESTING AND SYRINGE TYPE IDENTIFIED IN THE LOG REVIEW. TESTING VS. BACKPRESSURE FOUND THAT WHEN THE DEVICE REACHED BETWEEN 4.5 TO 5.5 PSI BACKPRESSURE THE PLUNGER HEAD COULD BE HEARD SLIPPING BACK TO THE ORIGINAL STARTING POINT. IT WAS NOTED IN THE DEVICES ERROR LOG THAT THE SYRINGE CALIBRATION REQUIRED ERROR CODE (351.6660) HAD OCCURRED DURING PRIOR USAGE BUT APPARENTLY WAS NOT ADDRESSED BY THE CUSTOMER AT THAT TIME, AND THE DEVICE WAS NOT TAKEN OUT OF SERVICE. PROXIMATE CAUSE OF THE SLIPPING BACK CONDITION RESULTING IN THE UNDERINFUSION EVENT WAS DETERMINED TO BE A DAMAGED SPLIT NUT ASSEMBLY. ROOT CAUSE IS UNDETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PT DID NOT GET OPIOIDS BECAUSE BACK PRESSURE WAS ENOUGH TO PREVENT IT FROM INFUSING. BIOMED DID MAINTENANCE TESTING AND FOUND DEVICE WILL PUMP WITH NO BACK PRESSURE; BACK PRESSURE WILL CAUSE THE PUMP TO SKIP DURING SPRING TEST CALIBRATION AND JUMP BACK. PCA WAS STARTED AT 18:00. CLINICIAN REPORTED DISCREPANCIES IN DOCUMENTATION THAT SHOW DILAUDID SYRINGE WAS NEAR EMPTY, BUT SYRINGE WAS FULL WHEN NURSE REMOVED IT NEXT MORNING AT 07:30 AM. THERE SHOULD HAVE BEEN 0.4ML LEFT IN THE SYRINGE. DIVERSION QUESTIONED AS WELL AS OTHER CLINICAL ISSUES. CONCENTRATION 0.2MG/ML - 25ML SYRINGE. PT-CONTROLLED ANALGESIA (PCA): HYDROMORPHONE, DOSE: 0.2 MILLIGRAMS, LOCKOUT INTERVAL: 8 MINS, MAX LIMIT: 5 MILLIGRAMS. PT WAS GIVEN ORAL PAIN MEDICATION AND THIS WAS NOT PART OF THE PAIN MANAGEMENT PROTOCOL. NO ADD'L INFO WAS PROVIDED ALTHOUGH REQUESTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PCA MODULE MEA CAREFUSION CORPORATION 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention ALARIS SYSTEM PC UNIT, SN (B)(4)