BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PUMP 40 ML

    MDR report key: 3230180 · Received July 16, 2013

    Report

    Report Number
    1226348-2013-21333
    Event Type
    Injury
    Date Received
    July 16, 2013
    Date of Event
    June 27, 2013
    Manufacturer
    CODMAN & SHURTLEFF,INC.
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    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 WILL NOT BE RETURNED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE DEVICE WAS NOT RETURNED AS IT IS STILL IMPLANTED IN THE PATIENT. THE INVESTIGATION OF THIS COMPLAINT IS BASED ON A WORKSHEET PROVIDED BY THE CUSTOMER. FOLLOWING THE MISCALIBRATED FLS IDENTIFICATION PROCEDURE WORKSHEET FILLED AND PROVIDED BY THE CUSTOMER, IT HAS BEEN OBSERVED THAT THE MEDSTREAM HAS A NEGATIVE OFFSET OF APPROX. 3.09ML WHICH IS SLIGHTLY OVER THE ACCEPTABLE ERROR (= 3ML), AS DESCRIBED IN THE ¿WORKSHEET TO IDENTIFY PUMPS WITH A MISCALIBRATED FLS¿. IT HAS BEEN OBSERVED THAT THE CONTROL PERFORMED BY THE SURGEON WAS NOT STRICTLY FOLLOWING THE CODMAN RECOMMENDATION. THE SURGEON HAS FILLED THE PUMP WITH 40ML AND NOT 30ML AS RECOMMENDED BY CODMAN. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THIS DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. A (B)(4) HAS BEEN OPENED TO INVESTIGATE THE COMPLAINT. 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.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE CALCULATED FAILURE IS GREATER THAN 3ML. IT WAS ACTUALLY 3.09ML. THE PUMP IS STILL IMPLANTED.

    Description of Event or Problem · 1

    THIS COMPLAINT BELONGS TO THE MEDSTREAM RECALL. THE CALCULATED FAILURE IS GREATER THAN 3ML IT IS ACTUALLY 3,09ML. PUMP IS STILL IMPLANTED. THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    328849 MEDSTREAM PUMP 40 ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF,INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention