BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODEL 3000-30ML VOLUME, HIGH FLOW IMPLANTABLE PUMP

    MDR report key: 3912251 · Received July 3, 2014

    Report

    Report Number
    1226348-2014-11791
    Event Type
    Malfunction
    Date Received
    July 3, 2014
    Manufacturer
    CODMAN & SHURTLEFF, INC
    Product Code
    LKK
    PMA / PMN Number
    PP890055
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    NURSE

    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 STILL IMPLANTED.

    Description of Event or Problem · 1

    CLINICAL NURSE SPECIALIST REPORTED THAT A CONVERSATION THAT SHE HAD WITH A PATIENT¿S WIFE RE HIS HAI NOW NON WORKING PUMP. PATIENT HAD A 3000H PUMP IMPLANTED BY THE SURGEON AT (B)(6) IN (B)(6) 2013. PATIENT'S WIFE BELIEVED THAT THE RN¿S WERE NOT EDUCATED ON USE OF THE PUMP. THE ONCOLOGY RN¿S APPARENTLY HAD TROUBLE ACCESSING THE PUMP, BUT DID MANAGE EVENTUALLY. HE RECEIVED ONE AND HALF ROUNDS OF CHEMO VIA THE PUMP. AS PER THE PATIENT¿S WIFE, THE PUMP CATHETER THEN THROMBOSED, AND AS PER THE PATIENT¿S WIFE, NO MEASURES WERE TAKEN TO FLUSH THE BOLUS PATHWAY WITH A LOW DOSE HEPARIN AND OR TO TPA THE CATHETER, THEREBY MAKING IT IM POSSIBLE TO CONTINUE THE PATIENTS THERAPY. THE PATIENT HAD TO HAVE ANOTHER SURGERY (BOWEL RESECTION) AND AT THAT SAME TIME WAS TOLD THAT THE CATHETER/PUMP WERE NO LONGER WORKING. THE LIVER METS HAS REAPPEARED, AND THE WIFE IS CONCERNED THAT THE PUMP CAN NO LONGER BE USED TO DELIVER CHEMO TO THE LIVER, DUE TO POSSIBLE MISMANAGEMENT. I DID ASSURE HER THAT IN SOME PATIENTS, A CATHETER CAN CLOT EASILY, DESPITE HEPARIN BEING IN THE LINE. I DID TELL HER THAT WE ARE NORMALLY AT SURGERIES AND ALSO DO MEDICAL ONCOLOGY FOLLOW UPS. WE EDUCATE THE STAFF WITH REGARD TO USING AND TROUBLESHOOTING THE HAI PUMP. IF THEY HAVE SOMEONE WHO HAS WORKED WITH AN HAI PUMP IN THE PAST, THEN WE FEEL COMFORTABLE THAT THE OFFICE CAN LOOK AFTER THE PATIENT. THE WIFE INFORMED ME THAT THEY DID HAVE SOMEONE IN THE OFFICE WHO HAD WORKED WITH AN HAI PUMP, IN THE PAST. I DID FOLLOW UP WITH REP, AS HE TOOK OVER THIS TERRITORY. HE WAS TOLD BY SURGEON , THAT HE WAS AWARE OF WHAT TO DO, AND DID NOT REQUIRE ANYONE FROM THE COMPANY IN THE OR DURING A PROCEDURE. WIFE WAS CONCERNED RE THE THROMBOSIS AT THE TIP OF THE CATHETER, AND I ASKED HER IF HER HUSBAND WAS ON AN ANTICOAGULANT, TO WHICH SHE ANSWERED IN THE AFFIRMATIVE. I AM NOT SURE WHAT THE TRUE PURPOSE WAS FOR HER CALL . I DID FEEL THE NEED TO REPORT THE CONVERSATION. (B)(4) 2014 IN FURTHER DISCUSSION WITH THE CLINICAL NURSE SHE INDICATED THAT THE CONCERNS EXPRESSED BY THE PATIENT'S WIFE APPEAR TO BE ATTRIBUTED TO THE PATIENT'S CONDITION AND NOT NECESSARILY TO THE PUMP. THE PATIENT IS AT THE FINAL STAGES OF HIS DISEASE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    390903 MODEL 3000-30ML VOLUME, HIGH FLOW IMPLANTABLE PUMP PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN & SHURTLEFF, INC

    Patients

    Seq Age Sex Outcome Treatment
    1