BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 5537518 · Received March 31, 2016

    Report

    Report Number
    1314492-2016-01882
    Event Type
    Injury
    Date Received
    March 31, 2016
    Date of Event
    March 3, 2016
    Report Date
    March 3, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE INITIAL REPORT WAS REPORTED IN ERROR. THE DEVICE WAS ABLE TO BE REPAIRED AND RETURNED TO THE CUSTOMER. THE STATEMENT "THIS UNAUTHORIZED REPAIR PERFORMED OUTSIDE THE FACTORY EXPOSED THE INTERNAL ESD SENSITIVE COMPONENTS, COMPROMISING ALL INTERNAL ELECTRICAL COMPONENTS RENDERING THE UNIT IRREPARABLE" IS INCORRECT.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE REPORTED "OVER INFUSION," WHICH WAS CONFIRMED AND REPRODUCED WHILE TESTING THE DEVICE AT VARIOUS FLOW RATES. BAXTER'S DEVICE EVALUATION FOUND THE DEVICE TO OVER DELIVER BY APPROXIMATELY 291.08% TO 433.80% WHEN THE DEVICE WAS DELIVERING AT A RATE OF 30ML/HR DURING FLOW RATE TESTING. THE EVALUATION DETERMINED THE CAUSE OF THE OVER INFUSION TO BE THE PUMP DOOR HOOK SHIMS HAD BEEN REMOVED WHILE IN THE FIELD. THIS UNAUTHORIZED REPAIR PERFORMED OUTSIDE THE FACTORY EXPOSED THE INTERNAL ESD SENSITIVE COMPONENTS, COMPROMISING ALL INTERNAL ELECTRICAL COMPONENTS RENDERING THE UNIT IRREPARABLE. IN THE WARNINGS AND CAUTIONS OF THE SPECTRUM OPERATORS MANUAL, IT STATES "SERVICING THE SIGMA SPECTRUM INFUSION SYSTEM IS RESTRICTED TO QUALIFIED, SIGMA TRAINED, SERVICE PERSONNEL WHO EMPLOY SIGMA AUTHORIZED PARTS AND PROCEDURES. USE OF OTHER PARTS AND SERVICING PROCEDURES IS PROHIBITED." THE DOOR HOOK SHIMS WERE REPLACED TO CORRECT THE CONDITION. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SIGMA SPECTRUM PUMP OVER INFUSED HEPARIN TO A PATIENT DURING THERAPY IN THE SURGICAL UNIT ON (B)(6) 2016. THE PATIENT WAS ADMITTED WITH A DIAGNOSIS OF RIGHT LOWER EXTREMITY DVT (DEEP VEIN THROMBOSIS) STATUS POST RIGHT TOTAL KNEE REPLACEMENT ON (B)(6) 2016, A KNOWN COMPLICATION OF POST OPERATIVE PROCEDURES. THE PUMP WAS PROGRAMMED AT 01:00AM TO DELIVER 25,000 UNITS OF HEPARIN IN 500ML (UNKNOWN IV FLUID) WITH A DOSE OF 1,500 UNITS/HR, INFUSING AT A RATE OF 30ML/HR. AT 05:45AM THE PUMP ALARMED; A NURSE RESPONDED, OBSERVED THE HEPARIN BAG TO BE EMPTY AND THE PUMP WAS TURNED OFF AT THAT TIME. THE PROGRAMMING ON THE PUMP WAS REVIEWED AND IT DISPLAYED VTBI: 362MLS , VOLUME GIVEN: 138ML AND 12 HOURS REMAINING ON THE INFUSION. THE NURSE OBTAINED ORDERS TO DRAW PTT (PARTIAL PROTHROMBIN TIME). DATE, TIME AND RESULTS OF PTT ARE AS FOLLOWS (LABWORK PERFORMED 5 TIMES): (B)(6) 2016 PTT DRAWN AT 0723 RESULT > 400 (CRITICAL RESULT); (B)(6) 2016 PTT DRAWN AT 1002 RESULT 127.2; (B)(6) 2016 PTT DRAWN AT 1724 RESULT 25.2; (B)(6) 2016 PTT DRAWN AT 2329 RESULT 35.7; (B)(6) 2016 PTT DRAWN AT 0537AM RESULT 35.5. THE PATIENTS PTT STABILIZED AND WAS DISCHARGED TO HOME IN STABLE CONDITION. ALL THE INFORMATION REGARDING THE PATIENT AND EVENT REPORTED TO BAXTER BY THE CUSTOMER HAS BEEN REFLECTED IN THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    193762 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Other| R