BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

    MDR report key: 3232875 · Received July 18, 2013

    Report

    Report Number
    1226348-2013-21487
    Event Type
    Injury
    Date Received
    July 18, 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 AND/OR LOT INFORMATION IS NOT AVAILABLE FOR EVALUATION. WITHOUT THE DEVICE AND/OR LOT INFORMATION IT IS NOT POSSIBLE FOR CODMAN TO CONDUCT A PROPER INVESTIGATION. IF AT SOME POINT THE DEVICE AND/OR LOT INFORMATION 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 RETURNED.

    Additional Manufacturer Narrative · 1

    PLEASE BE ADVISED THAT PER THE NEW MATRIX ON (B)(6) 2013 THIS EVENT IS BEING RE-CLASSIFIED AS A SERIOUS INJURY.

    Additional Manufacturer Narrative · 1

    UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE MEDSTREAM PUMP WILL NOT BE RETURNED FOR INVESTIGATION AND THEREFORE THE INVESTIGATION WAS BASED ON THE INFORMATION PROVIDED BY THE CUSTOMER WHEN COMPLETING THE WORKSHEET THAT IDENTIFIES PUMPS THAT HAVE A FILL LEVEL SENSOR (FLS), THAT MIGHT HAVE BEEN MISCALIBRATED. BASED ON THE INFORMATION PROVIDED ON THE FORM, IT HAS BEEN OBSERVED THAT THE MEDSTREAM PUMP 91-4200, SN:(B)(4), HAS A NEGATIVE OFFSET OF APPROX. 3.15ML, WHICH IS SLIGHTLY OVER THE ACCEPTABLE ERROR (= 3ML). IT HAS BEEN OBSERVED THAT THE TESTING OF THE FLS PERFORMED BY THE SURGEON WAS NOT STRICTLY FOLLOWED BY THE CODMAN RECOMMENDATION. THE SURGEON HAS FILLED THE PUMP WITH 20ML AND NOT 15ML AS RECOMMENDED BY CODMAN. IT IS NOT KNOWN IF THIS IMPACTED THE RESULT OBTAINED. A DEVICE HISTORY RECORDS REVIEW WAS PERFORMED AND NO DISCREPANCIES WERE OBSERVED DURING THE MANUFACTURING PROCESS. (B)(4) HAS BEEN OPENED TO INVESTIGATE THE ROOT CAUSE AND A FIELD SAFETY CORRECTIVE ACTION HAS BEEN OPENED IN EUROPE. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    AFFILIATE REPORTED A MISCALIBRATED FILL LEVEL SENSOR OF 3.15 ML. NO OTHER DETAILS WERE REPORTED.

    Description of Event or Problem · 1

    PLEASE BE ADVISED THAT PER THE NEW MATRIX ON (B)(6) 2013 THIS EVENT IS BEING RE-CLASSIFIED AS A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    333452 MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention