BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PCA MODULE

    MDR report key: 3170754 · Received May 22, 2013

    Report

    Report Number
    2016493-2013-00243
    Event Type
    Malfunction
    Date Received
    May 22, 2013
    Date of Event
    April 20, 2013
    Report Date
    April 25, 2013
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K032233
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). NO DEVICES RECEIVED, LOG REVIEW ONLY. CONCLUSION: FIELD LEFT BLANK- NO AVAILABLE CODE FOR UNDETERMINED OR UNKNOWN CAUSE. THE CUSTOMER'S REQUEST FOR A LOG REVIEW FOR A POSSIBLE OVERINFUSION OF MORPHINE HAS BEEN COMPLETED. A REVIEW OF THE ASSOCIATED PCU EVENT LOG FOR THE MORPHINE INFUSION FOUND THAT THE MEDICATION WAS MORPHINE, THE CONCENTRATION WAS 1 MG/1 ML (30 MG/30ML) AND THE PROGRAMMING WAS 1 MG PCA DOSE, 8 MINUTE LOCKOUT, AND A 4 HOUR LIMIT OF 30 MG AS REPORTED BY THE CUSTOMER. THE SYRINGE IN USE DURING THE PROGRAMMING IN QUESTION, HOWEVER, CONTAINED ONLY A 19.44 ML STARTING VOLUME WHICH MAY HAVE LED TO THE PERCEPTION OF AN OVERINFUSION. THE ROOT CAUSE OF THE CUSTOMER'S EXPERIENCE WAS NOT DETERMINED. NO DEVICE MALFUNCTION IS BELIEVED TO HAVE OCCURRED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A POSSIBLE OVER INFUSION. MEDICATION WAS MORPHINE, CONCENTRATION 1MG/1ML (30ML VIAL). INTENDED PROGRAMMING 1MG, 8 MINUTE LOCKOUT, 4 HOUR LIMIT 30MG. THE MODULE PASSED BIOMED'S FUNCTIONAL TESTING. AN EVENT LOG REVIEW WAS REQUESTED. THERE WAS NO PATIENT HARM OR MEDICAL INTERVENTION REQUIRED. CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    226987 ALARIS PCA MODULE FRN CAREFUSION CORP. 8120 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR SPO2 SENSOR, MODEL/LOT UNK| ALARIS PUMP MODULE ADMIN SET, MODEL/LOT UNK| IMS SYRINGE, MODEL/LOT UNK| ALARIS PUMP MODULE, SN (B)(4)| ALARIS SPO2 MODULE, SN (B)(4)| ALARIS PC UNIT, SN (B)(4)