BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 3841423 · Received May 30, 2014

    Report

    Report Number
    1226348-2014-11695
    Event Type
    Malfunction
    Date Received
    May 30, 2014
    Date of Event
    May 20, 2014
    Manufacturer
    CODMAN & SHURTLEFF
    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

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE MEDSTREAM PUMP WAS NOT RETURNED FOR INVESTIGATION AS IT WAS NOT EXPLANTED. THE LOCAL TECHNICAL SUPPORT SALES REPRESENTATIVE HAS BEEN IN (B)(6) TO INVESTIGATE WHETHER IT WAS POSSIBLE TO CLEAR THE ERRORS FLAGS OF THE PUMP, AND RESTART THE PROGRAM. THE COMPLAINT WAS CONFIRMED BASED ON THE INFORMATION COLLECTED BY THE LOCAL SALES REPRESENTATIVE ON MAY 21ST 2014. IT HAS BEEN SHOWN THAT THE PUMP HARDWARE FAILURE WAS NOT RELATED TO THE PUMP HARDWARE INTEGRITY, BUT MOST PROBABLY TO AN INTERFERENCE WITH THE MRI EXAMINATION ONTO THE PUMP. CORRECTIVE ACTION (B)(4) 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 THIS CAPA. THE VALUES PROVIDED ARE CONSISTENT WITH THE EXPECTED STATUS AND SENSOR MEASUREMENTS. THE CORRESPONDING TEMPERATURE MEASUREMENT IS 37.69°C, AND THE FLS FREQUENCY MEASUREMENT IS 267802 HZ WHICH CORRESPONDS TO 19.41 ML. A DHR REVIEW WAS PERFORMED FOR THE MEDSTREAM PUMP 91-4201 SN# (B)(4), (LOT# CKJBGL), AND IT WAS OBSERVED THAT THE LOT MET SPECIFICATIONS WHEN RELEASED TO STOCK. BASED ON THE RESULTS OF THIS INVESTIGATION NO FURTHER ACTION IS REQUIRED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR COMPLAINTS. AT THE PRESENT TIME THIS COMPLAINT IS CLOSED. COMPLAINT SAMPLE NOT RETURNED.

    Description of Event or Problem · 1

    IT WAS REPORTED BY OUR LOCAL REPRESENTATIVE A HW11 ERROR ON A MEDSTREAM PUMP AFTER MRI EXAM. THE PUMP WAS IMPLANTED 4 YEARS AGO. THE PUMP WILL REMAINS IMPLANTED. ADDITIONAL INFORMATION ((B)(4) 2014): THE PUMP WAS BIPPING WHEN THE ISSUE OCCURRED, IT WAS FILLED WITH MORPHINE. ADDITIONAL INFORMATION ((B)(4) 2014): THE PATIENT HAD WITHDRAWAL SYMPTOMS. (B)(4) 2014 YES I CONFIRM, THIS PUMP WAS MANUFACTURED WITH THE OLD IFU (NEW IFU IMPLEMENTATION DATE: (B)(4) 2010). THE PUMP INVOLVED IN THE COMPLAINT WAS MANUFACTURED ON JULY 9TH 2010. (B)(4) 2014 DEAR (B)(4), THE PUMP RESTARTED WITH THE TECHNICAL KEY. WE CONSIDER THIS COMPLAINT AS NON MDV REPORTABLE AS IT IS SIDE EFFECT WHICH IS DESCRIBED IN THE IFU. BEST REGARDS (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    318238 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF CKJBGL

    Patients

    Seq Age Sex Outcome Treatment
    1