BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML

    MDR report key: 3203850 · Received July 3, 2013

    Report

    Report Number
    1226348-2013-20255
    Event Type
    Injury
    Date Received
    July 3, 2013
    Date of Event
    June 13, 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

    THE COMPLAINT WAS RE-OPENED AS THE TRANSACTION LOGS BECAME AVAILABLE FOR ANALYSIS. UPON COMPLETION OF THE INVESTIGATION IT WAS NOTED THAT THE TRANSACTION LOGS WERE ANALYZED. DISCREPANCIES WERE NOTED BETWEEN THE VOLUME CALCULATED BASED ON THE PROGRAMMED FLOW RATE AND THE VOLUME MEASURED BY THE FLS (WRITTEN ON THE TRANSACTION LOGS). THE FLS MEASUREMENTS WERE CONSISTENT WITH THE INJECTED AND RECOVERED VOLUMES. THE RESERVOIR WAS FOUND EMPTY TOO EARLY ON JUNE 13TH 2013, WITH APPROX 4.6ML MISSING FROM THE RESERVOIR. RECOMMENDED STEPS WERE FOLLOWED BY THE SURGEON AND THE FLS MEASUREMENT (PUMP INTERROGATION) 3 DAYS LATER, ON JULY 19TH, SHOWED THAT THE REMAINING VOLUME WAS CONSTANT WHEN THE PUMP WAS IN STOP INFUSION: THE PUMP RESERVOIR DOES NOT LEAK. FOLLOWING PIB RECOMMENDATION, SURGEON RESTARTED THE PUMP PROGRAM AT THE LAST PROGRAMMED FLOW RATE (0.2ML/DAY) WITH THE RESERVOIR STILL FILLED WITH SALINE WATER. THE PUMP INTERROGATION ONE WEEK LATER (ON JULY 26TH) INDICATED A FLOW WITHIN SPECIFICATION. THE PUMP INTERROGATION TWO WEEKS LATER (ON AUGUST 2ND) INDICATED A PUMP RESERVOIR EMPTY, TOO EARLY IN COMPARISON WITH THE EXPECTATIONS FOR A THIRD TIME. THE PHYSICIAN DECIDED TO REFILL THE PUMP WITH 20ML OF SALINE WATER. DURING THE REFILL, THE COMMUNICATION BETWEEN THE CU 07M01551 AND THE PUMP WAS NOT POSSIBLE ANYMORE. NO INFORMATION HAS BEEN PROVIDED ON THE PUMP STATUS SINCE THEN. THE PUMP WILL NOT BE RETURNED FOR INVESTIGATION. IN CONCLUSION THE PUMP WAS FOUND EMPTY EARLIER THAN EXPECTED. SINCE THE ROOT CAUSE OF THE PROBLEM COULD NOT BE IDENTIFIED A CAPA HAS BEEN OPENED TO INVESTIGATE THE PROBLEM. A REVIEW OF THE DEVICE HISTORY RECORDS CONFIRMED THAT THE DEVICE CONFORMED TO THE REQUIRED SPECIFICATIONS PRIOR TO DISTRIBUTION. 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. DEVICE NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED FROM MALFUNCTION TO SERIOUS INJURY.

    Description of Event or Problem · 1

    THE AFFILIATE REPORTED THAT THE PUMP WAS FOUND EMPTY 7 DAYS BEFORE THE SCHEDULED REFILL PROCEDURE. THE SURGEON WAS SURPRISED THAT THE PUMP WAS EMPTY. THE PUMP WAS IMPLANTED AND FILLED WITH BACLOFEN 100 MCG/ML FOR A DAILY FLOW RATE OF 200MG/DAY. IT WAS IMPOSSIBLE TO ESTABLISH A COMMUNICATION BETWEEN THE CU AND PUMP AFTER THE REFILL PROCEDURE WHICH INCLUDED A CHANGE IN DRUG DOSAGE FOR THE PATIENT. THERE WERE NO SIGNS OF AN OVERDOSE.

    Description of Event or Problem · 1

    THE PUMP WAS FOUND EMPTY 7 DAYS BEFORE THE SCHEDULED TIME FOR THE REFILL PROCEDURE. THE SURGEON WAS SURPRISED THAT THE PUMP WAS ALREADY EMPTY WHEN THE NEXT TIME FOR REFILL WAS SCHEDULED AFTER A WEEK. THE PUMP WAS IMPLANTED ON (B)(6) 2012 IN (B)(6), FILLED WITH BACLOFEN 100MCG/ML FOR A DAILY FLOW RATE OF 200MG/DAY. IT WAS IMPOSSIBLE TO ESTABLISH A COMMUNICATION BETWEEN CU AND PUMP AFTER A REFILL PROCEDURE WITH CHANGING OF DRUG DOSAGE FOR THE PATIENT. THERE WERE NO SIGNS OF UNDER OR OVERDOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    306106 MEDSTREAM PROGRAMMABLE INFUSION PUMP 20ML PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC. CNLBZJ

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention