BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON

    MDR report key: 1609739 · Received February 19, 2010

    Report

    Report Number
    6000001-2010-00195
    Event Type
    Malfunction
    Date Received
    February 19, 2010
    Date of Event
    January 31, 2010
    Report Date
    February 3, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEA
    PMA / PMN Number
    K002739
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION: THE DEVICE IS AVAILABLE FOR EVALUATION, PER THE CUSTOMER, HOWEVER, THE DEVICE HAS YET TO BE RECEIVED AT BAXTER. SHOULD THE DEVICE OR ADDITIONAL INFORMATION BE RECEIVED, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS IS A NOT STAND-ALONE DEVICE AND MUST BE USED IN CONJUNCTION WITH AN INFUSOR DEVICE. SEE MDR REPORT #6000001-2010-00194 FOR THE REPORT ASSOCIATED WITH THE INFUSOR.(B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) A CE 2 ML PATIENT CONTROL MODULE WAS USED IN CONJUNCTION WITH A BASAL/BOLUS INFUSOR WHEN THE DEVICE OVERINFUSED DURING PATIENT USE. THE DEVICE WAS FILLED WITH 9ML MORPHINE HYDROCHLORIDE, 24ML NORMAL SALINE, AND 3ML LORFAN. THE TOTAL FILL VOLUME WAS 36ML. THERAPY BEGAN AT 9:25 AM ON (B)(6) 2010. ACCORDING TO THE CUSTOMER, ABOUT 2 HOURS AFTER THERAPY BEGAN, THE PATIENT CONTROL MODULE (PCM) WAS USED. AT 5:00 PM, A NURSE FOUND THE RESIDUAL DRUG IN THE RESERVOIR TO BE LESS THAN EXPECTED. AT 10:00 PM, THE DEVICE WAS STILL FLOWING FASTER THAN EXPECTED, BUT THE PATIENT'S CONDITION WAS GOOD AND THE MEDICATION CONTINUED UNTIL 4:00 AM (B)(6) 2010 WHEN DELIVERY ENDED. THE DEVICE WAS EXPECTED TO DELIVER IN 3 DAYS (72 HOURS), HOWEVER, THE ACTUAL INFUSION TIME WAS 19 HOURS. THE TEMPERATURE OF THE DEVICE WAS UNKNOWN AND THE HEIGHT OF THE RESTRICTOR WAS THE SAME AS THE RESERVOIR. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE 2 ML PATIENT CONTROL MODULESINGLE PACK 6/CARTON PUMP, INFUSION, PCA MEA BAXTER HEALTHCARE - IRVINE

    Patients

    Seq Age Sex Outcome Treatment
    1