BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 4863483 · Received June 23, 2015

    Report

    Report Number
    1226348-2015-10369
    Event Type
    Malfunction
    Date Received
    June 23, 2015
    Date of Event
    June 2, 2015
    Manufacturer
    CODMAN & SHURTLEFF, INC. / MEDOS S.A.
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). IT HAS BEEN COMMUNICATED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. SINCE A LOT NUMBER HAS BEEN PROVIDED A REVIEW OF THE MANUFACTURING RECORDS WILL BE REVIEWED. WE ANTICIPATE THAT THE EVALUATION WILL REVEAL THAT THE DEVICE CONFORMED TO SPECIFICATIONS PRIOR TO RELEASE. IF ANYTHING OTHERWISE IS FOUND THEN A FOLLOW UP REPORT WILL BE FILED. IF AT SOME POINT THE DEVICE DOES BECOME AVAILABLE, THIS COMPLAINT WILL BE RE-OPENED, EVALUATED AND A FOLLOW UP REPORT WILL BE FILED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CONSIDERED CLOSED. DEVICE NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE PRODUCT WAS NOT RETURNED FOR INVESTIGATION SINCE IT WAS NOT EXPLANTED. BASED ON DATA COLLECTED, THE COMPLAINT WAS CONFIRMED. THE DEVICE HISTORY RECORD OF PRODUCT CODE 91-4201, LOT CJMD2J; SERIAL NUMBER (B)(4) WAS REVIEWED AND CONFIRMED THAT THE PRODUCT WAS CONFORMED TO THE SPECIFICATIONS WHEN RELEASED ON DECEMBER 03RD, 2008. IT HAS BEEN SHOWN THAT THE PUMP FAILURE WAS NOT RELATED TO THE PUMP HARDWARE INTEGRITY, BUT MOST PROBABLY TO A POSSIBLE INTERFERENCE WITH THE MRI EXAMINATION ONTO THE PUMP, THIS HOWEVER COULD NOT BE DETERMINED. CORRECTIVE ACTION WAS IMPLEMENTED TO AVOID THIS DEFECT, EFFECTIVENESS HAS BEEN DEMONSTRATED FOR PUMPS MANUFACTURED AFTER CAPA IMPLEMENTATION ((B)(4) 2010). THE PUMP INVOLVED IN THIS COMPLAINT WAS MANUFACTURED PRIOR THE IMPLEMENTATION OF THE CAPA. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED.

    Description of Event or Problem · 1

    THE PATIENT ATTENDED AN MRI APPOINTMENT ON (B)(6) 2015 & THEIR PUMP WAS WORKING PRIOR TO THE MRI, HAVING CHECKED IT MYSELF. I PROCEEDED TO STOP THE INFUSION PRIOR TO THE MRI, BASED ON THE ADVICE GIVEN TO ME. AFTER THE MRI, THE PUMP REPORTED A HARDWARE 11 FAULT. AFTER COLLECTING THE NECESSARY DATA & SPEAKING WITH SOMEONE ON A PRE-ARRANGED PIB, I WAS THEN INSTRUCTED TO CLEAR THE ERROR FLAGS & RE-START THE PROGRAM. I SOUGHT PERMISSION. THE PATIENT EXPERIENCED NO SYMPTOMS, OTHER THAN MILD FRUSTRATION AT THE DELAY OF LEAVING THE HOSPITAL. DEVICE REMAINS IN PATIENT, ORIGINALLY IMPLANTED (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    405492 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC. / MEDOS S.A. CJMD2J

    Patients

    Seq Age Sex Outcome Treatment
    1