BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS SYRINGE PUMP MODULE

    MDR report key: 3872534 · Received May 21, 2014

    Report

    Report Number
    2016493-2014-00262
    Event Type
    Malfunction
    Date Received
    May 21, 2014
    Date of Event
    February 1, 2014
    Report Date
    May 6, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS REPORT WAS FILED BY THE MANUFACTURER. DEVICES NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS HAVE BEEN RECEIVED AND THE EVALUATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVALUATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED POSSIBLE VERSED OVER INFUSION IN THE CARDIAC ICU. THER VERSED CONCENTRATION WAS 1MG/ML AND THE INTENDED PROGRAMMING WAS 0.5ML/HOUR AND A BOLUS WAS ADMINISTERED AT 0600 ON (B)(6) 2014 AND AT 1800 ON (B)(6) 2014 PER MEDICATION SHEET. CUSTOMER SUSPECTS AT SOME TIME DURING THE INFUSION A 5ML BOLUS MAY HAVE BEEN GIVEN SINCE THERE IS ABOUT 4MLS OF MEDICATION MISSING AT THE END OF THERAPY. CUSTOMER REQUESTS AN EVENT LOG REVIEW FROM 0001 ON (B)(6) 2014 TO 2359 ON (B)(6) 2014 TO HELP THEM ACCOUNT FOR THE MISSING VOLUME. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    303391 ALARIS SYRINGE PUMP MODULE FRN CAREFUSION CORPORATION 8110 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT: SN (B)(4)| B-D 50ML SYRINGE: MODEL/LOT UNK| EXTENSION SET: MFR/MODEL/LOT UNK