BEUDAMED
    FDA Adverse Event Injury Summary report: N

    EXACTAMIX EVA CONTAINER 3000ML

    MDR report key: 4185965 · Received October 20, 2014

    Report

    Report Number
    1419106-2014-00011
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    August 28, 2014
    Report Date
    October 20, 2014
    Manufacturer
    BAXTER CORPORATION
    Product Code
    LHI
    PMA / PMN Number
    K900585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION CODES: METHOD: - NO TESTING METHODS PERFORMED. RESULTS: - NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED. CONCLUSIONS: - DEVICE NOT RETURNED. NARRATIVE: PRODUCT IS EXPECTED TO RETURN IN THE FUTURE AND THE RGA LABELS ARE BEING MAILED TO THE CUSTOMER IN ORDER TO FACILITATE THE RETURN. IN AN EFFORT TO MEET THE DEADLINE OF THE MEDWATCH, A PRELIMINARY EVALUATION WILL BE CONDUCTED SINCE THREE DUE DILIGENCE ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE SAMPLES. WITHOUT PRODUCT RETURNING, THE COMPLAINT CANNOT BE CONFIRMED AND THE EXACT ROOT CAUSE WILL REMAIN UNKNOWN. IF/WHEN PRODUCT RETURNS, THE SAMPLES WILL BE EVALUATED BY THE QUALITY ENGINEERS. ALTHOUGH WE ARE NOT ABLE TO EVALUATE THE SAMPLES, A THOROUGH INVESTIGATION HAS BEEN CONDUCTED ON THIS CASE. THE PREVIOUS PHARMACY(B)(6) USED ALL BAXTER PRODUCTS ON THE EM2400 COMPOUNDER TO MAKE A SPECIALLY FORMULATED TPN BAG FOR THE CUSTOMER. THE CUSTOMER DID NOT EXPERIENCE ANY ALLERGIC REACTIONS TO THOSE BAGS. THE PHARMACIST AT (B)(6) STATES HE REVIEWED HIS PROCESS AND ISOLATED TWO POSSIBLE SOURCES OF LATEX CONTAMINATION FROM THE INGREDIENTS USED. HE NOTED THAT THE SODIUM ACETATE (100ML) VIAL CAME FROM HOSPIRA. THAT VIAL HAD A RUBBER STOPPER WITH POSSIBLE LATEX CONTAMINATION. HE CONFIRMED WITH HOSPIRA THAT THE 50ML VIAL OF SODIUM ACETATE DID NOT HAVE LATEX IN THE RUBBER STOPPER. HE ALSO NOTED THAT THE ZINC INGREDIENT MAY HAVE CONTAINED THE SECOND SOURCE OF LATEX CONTAMINATION. SO HE SWITCHED TO PULLING ZINC FROM A SYRINGE TO AVOID ANY LATEX CONTAMINATION ON THE RUBBER STOPPER OF THE ZINC VIAL. HE REMOVED THE POSSIBLE CONTAMINATED INGREDIENTS FROM THE COMPOUNDER MACHINE, REPLACED THEM WITH LATEX FREE INGREDIENTS, AND ATTACHED NEW TUBE SETS. THE PHARMACIST CONFIRMED THAT HIS GLOVES WERE LATEX FREE, THE SYRINGES WERE ALL LATEX FREE, AND THE CURLIN (AMBULATORY ELECTRONIC INFUSION PUMP) THAT ADMINISTERS THE TPN BAG WAS ALSO LATEX FREE. EVEN AFTER REVIEWING HIS SET-UP AND REMOVING THE POSSIBLE SOURCES OF CONTAMINATION, THE CUSTOMER STILL EXPERIENCED AN ALLERGIC REACTION TO EVERY BAG (B)(4) MADE FOR (B)(6). ADDITIONALLY, (B)(6) REPORTED SHE SUSPECTED THAT THE PEPCID INGREDIENT SHE WAS MANUALLY ADDING TO THE TPN BAGS FROM (B)(4) WAS CAUSING HER AN ALLERGIC REACTION. THEREFORE, SHE INFUSED WITH ONE TPN BAG THAT HAD ALL THE MANUALLY ADDED INGREDIENTS AND THEN INFUSED WITH THE NEXT BAG THAT DID NOT CONTAIN PEPCID. SHE REPORTED THAT SHE STILL EXPERIENCED THE ALLERGIC REACTION. THE EXACTAMIX 2400 COMPOUNDER EMPLOYS A NUMBER OF DISPOSABLE PRODUCTS AS PART OF THE OVERALL COMPOUNDING PROCESS. LATEX IS NOT CONTAINED IN THE COMPONENT MATERIAL BASE FORMULATION OR RAW MATERIALS OF ANY OF THOSE DISPOSABLES. LATEX IS NOT INTENTIONALLY ADDED TO THE COMPONENT MATERIAL DURING PRODUCTION OF THE MATERIALS OR DURING THE MANUFACTURING OF THE COMPONENTS. THE ASSOCIATES MANUFACTURING THE DISPOSABLES ALSO WEAR GLOVES THAT DO NOT CONTAIN LATEX.

    Description of Event or Problem · 1

    A PATIENT, (B)(6), CONTACTED BAXTER HEALTHCARE TO REPORT THAT SHE HAD ALLERGIC REACTIONS, WHICH RESULTED IN ANAPHYLACTIC SHOCK, AFTER SHE INFUSED WITH EXACTAMIX TPN BAGS (PART NUMBER 741, LOT NUMBER 1001921). THE PATIENT IS SEVERELY ALLERGIC TO LATEX. SHE IS ALSO ALLERGIC TO SULFUR AND MOST ANTIBIOTICS. SHE HAD A SMALL INTESTINE TRANSPLANT AT THE (B)(6) AND HAS BEEN ON TPN BAGS FOR A LONG TIME. CAPS (B)(6) COMPOUNDS TPN BAGS FOR (B)(6). SHE NEVER EXPERIENCED AN ALLERGIC REACTION WHILE USING THE TPN BAGS FROM THE (B)(6). AFTER SHE MOVED BACK HOME TO (B)(4) SHE STARTED TO RECEIVE HER TPN BAG SUPPLIES ON (B)(6) 2014. (B)(6) REPORTED THAT SHE HAD AN ALLERGIC REACTION TO THREE DIFFERENT TPN BAGS ON THREE DIFFERENT SHIPMENTS THAT WERE SUPPLIED BY (B)(4). SHE SUSPECTED THAT THE TPN BAGS WERE CONTAMINATED WITH LATEX. A PHARMACIST FROM (B)(6), STATES HE REVIEWED HIS PROCESS AND ISOLATED TWO POSSIBLE CONTAMINATION SOURCES. HE ADDRESSED THE ISSUES AND COMPOUNDED NEW BAGS ON THE LAST SHIPMENT. (B)(6) RECEIVED THE LAST SHIPMENT OF TPN BAGS ON (B)(6) 2014. THE PATIENT SAID SHE STARTED TO INFUSE WITH ONE BAG AND FELT THE REACTION COMING ON SO SHE STOPPED USING THE BAGS ALTOGETHER. ONCE SHE DISCONTINUED INFUSING WITH EACH (B)(4) BAG, SHE TOOK A BENADRYL AND INJECTED HERSELF WITH AN EPIPEN. HER SYMPTOMS OF ANAPHYLACTIC SHOCK SUBSIDED WITHOUT THE NEED FOR MEDICAL INTERVENTION. REFER TO THE SEPARATE ATTACHMENT, (B)(4) PATIENT INVOLVED QUESTIONNAIRE.PDF, FOR MORE INFORMATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    665744 EXACTAMIX EVA CONTAINER 3000ML 3000 ML TPN BAG LHI BAXTER CORPORATION H938741 1001921

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR