BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2251722 · Received August 31, 2011

    Report

    Report Number
    2016493-2011-00487
    Event Type
    Malfunction
    Date Received
    August 31, 2011
    Date of Event
    August 2, 2011
    Report Date
    August 17, 2011
    Manufacturer
    CARDINAL CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE CUSTOMER STATED THAT THE PRODUCT WILL NOT BE RETURNED AT THIS TIME PENDING LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN REC'D AND LOG REVIEW IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE INVESTIGATION HAS BEEN COMPLETED. DEVICE LOG REVIEW ANTICIPATED, BUT NOT BEGUN.

    Description of Event or Problem · 1

    BIOMED REQUESTED LOG REVIEW AND SENT LOGS AND DATA SET FOR REVIEW. NURSE STARTED A NEW BAG OF VERSED (1 MG/1 ML WITH A 100ML VOLUME) ON (B)(6) 2011 AT 2300. THE PUMP SHOULD HAVE BEEN PROGRAMMED AT 0.05MG/KG/HR. WITH PRIMING AND INFUSION THE CUSTOMER WOULD EXPECT 30 ML TO HAVE BEEN USED BETWEEN (B)(6) 2011 AT 2300 - (B)(6) 2011 AT 1000, BUT THE BAG WAS EMPTY AT 1000. THE VERSED WAS A PRIMARY INFUSION AND WAS NOT IN A LOCKED CONTAINER. DUE TO THE DISCREPANCY IN THE VOLUME, THE CUSTOMER WANTS TO VERIFY IF THE VERSED WAS PROGRAMMED CORRECTLY IN GUARDRAILS AND WHETHER THERE ARE ANY INDICATIONS OF TAMPERING. CUSTOMER STATED THAT THERE DID NOT APPEAR TO BE AN ACUTE ADVERSE EFFECT ON THE PT. THERE WAS NO REPORT OF MEDICAL INTERVENTION. CUSTOMER STATED THAT NO ADD'L EVENT OR PT INFO COULD BE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CARDINAL CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 YR ALARIS PC UNIT, S/N UNK| ALARIS PUMP MODULE ADMINISTRATION SET, LOT # UNK