BEUDAMED
    FDA Adverse Event Summary report: N

    EXACTAMIX¿ EMPTY EVA CONTAINER

    MDR report key: 2269713 · Received September 29, 2011

    Report

    Report Number
    1419106-2011-00012
    Date Received
    September 29, 2011
    Date of Event
    September 1, 2011
    Report Date
    September 1, 2011
    Manufacturer
    BAXA CORPORATION
    Product Code
    KPE
    PMA / PMN Number
    K900585
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    PER 3500A FOLLOW-UP INSTRUCTIONS MATERIAL SUBMITTED IN THE INITIAL REPORT WILL NOT BE REPEATED. THIS FOLLOW-UP ONLY CONTAINS ADDITIONAL INFORMATION. (B)(4). PRODUCT FROM THE REPORTED LOT WAS RECEIVED FOR EVALUATION; HOWEVER, THE GAMBRO SPIKE BEING USED WITH THE BAG WAS NOT RETURNED FOR EVALUATION. LAB TESTING WAS PERFORMED TO SIMULATE THE USER ENVIRONMENT BY USING A BAXA COMPOUNDER INLET SPIKE INSTEAD. WE WERE ABLE TO CONFIRM THE CUSTOMER'S REPORT THAT THE DIAPHRAGM WAS DIFFICULT TO PIERCE. WE NOTIFIED THE SUPPLIER OF THIS COMPLAINT. THE SUPPLIER RESPONSE FOR THIS COMPLAINT WAS RECEIVED ON (B)(4) 2011 AND STATED THAT THE ISSUE WOULD BE FURTHER INVESTIGATED UNDER A CORRECTIVE ACTION. BAXA IS NO LONGER USING THIS SUPPLIER AS A SUBCONTRACT MANUFACTURER.

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BEING FILED TO THE AGENCY FOR AWARENESS AND IS NOT DUE TO AN ADVERSE EVENT OR MALFUNCTION. IT IS BAXA'S COMPANY PROCEDURE TO FILE A MEDWATCH WHEN BECOMING AWARE OF A USER FACILITY MEDWATCH THAT REPORTS A BAXA PRODUCT. THE CUSTOMER WAS CONTACTED FOR ADDITIONAL INFORMATION AND STATED THERE WERE NO INJURIES OR ADVERSE EVENTS TO ANY PATIENTS AS A RESULT OF THIS EVENT. THE CUSTOMER REPORTED THAT WHEN THEY BECAME AWARE OF THE EVENT LOT #100298 WAS ALL THEY HAD IN STOCK; HOWEVER, THEY COULD NOT STATE WITH CERTAINTY THAT BAGS FROM OTHER LOTS HAD NOT BEEN ASSOCIATED WITH THE PROBLEM. THIS USER FACILITY UTILIZES THE GAMBRO PRISMA CRRT MACHINE AND GAMBRO TUBING TO CONNECT THE BAG TO THE DIALYSIS MACHINE. THE REPORTED DEVICE IS MANUFACTURED BY A SUPPLIER FLEX MEDICAL. THE SUPPLIER WAS NOTIFIED OF THE ISSUE AND PROVIDED A COPY OF THE MEDWATCH SUBMITTED BY THE FACILITY. PRODUCT HAS JUST BEEN RETURNED FOR EVALUATION OF THIS COMPLAINT AND INVESTIGATION IS PENDING; A FOLLOW-UP MDR WILL BE SUBMITTED AT THE CONCLUSION OF THAT INVESTIGATION.

    Description of Event or Problem · 1

    ON (B)(4) 2011, BAXA WAS NOTIFIED OF A CUSTOMER EVENT THAT RESULTED IN THE FILING OF A MEDWATCH REPORT. THE EVENT DESCRIPTION REPORTED IS AS FOLLOWS: "A RECURRING PROBLEM WITH BAXA CORPORATION EMPTY, 3-LITER, EXACTA-MIX EVA CONTAINER (THEIR REORDER NUMBER H938 141 3). WE USE THIS CONTAINER TO DELIVER CITRATE SOLUTION FOR OUR PATIENTS ON CVVH. WHEN THE ADMINISTRATION SET PORT (THE MIDDLE PORT) IS SPIKED, THE DIAPHRAGM IS SO VERY RESISTANT TO PENETRATION THAT IT CAUSES THE SPIKING NEEDLE TO CURL BACK ON ITSELF ON OCCASION WITH BUT A SINGLE SPIKING, AND MORE OFTEN WHEN MULTIPLE BAGS ARE SPIKED. THESE CVVH BAGS ARE CHANGED EVERY 2-3 HOURS AND THE ADMINISTRATION SET, COMPLETE WITH SPIKE, IS GOOD FOR 72 HOURS. NURSES HAVE TO FREQUENTLY REPLACE THE SPIKE BEFORE THE SET HAS TO BE REPLACED. THE CURL BACK INCREASES FLOW RESISTANCE AND CAUSES THE PUMP TO SHUT DOWN. WHEN THE PUMP SHUTS DOWN, THE CVVH FILTER HAS TO BE REPLACED AT A COST OF SEVERAL HUNDRED DOLLARS. NURSES FIND IT REQUIRES EXTRAORDINARY FORCE TO SPIKE THIS PARTICULAR BAXA CONTAINER. THE SAME SPIKE, WHEN USED WITH OTHER CONTAINERS, HAS NOT BEEN ASSOCIATED WITH THIS PROBLEM."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 EXACTAMIX¿ EMPTY EVA CONTAINER CONTAINER, IV KPE BAXA CORPORATION 141 NOT LIMITED TO 100298

    Patients

    Seq Age Sex Outcome Treatment
    1