BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 6051673 · Received October 24, 2016

    Report

    Report Number
    1314492-2016-04961
    Event Type
    Malfunction
    Date Received
    October 24, 2016
    Date of Event
    September 1, 2016
    Report Date
    November 16, 2016
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K042121
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE AWARE DATE OF THE INITIAL MANUFACTURER REPORT WAS INCORRECT. THE AWARE DATE FOR THE INITIAL REPORT IS (B)(6) 2016.

    Additional Manufacturer Narrative · 1

    (B)(4). BAXTER RECEIVED AND EVALUATED THE DEVICE. EVALUATION CONFIRMED THE REPORTED SYMPTOM "DOOR SHIMS" THROUGH OBSERVATION OF THE DIRECTION OF FLOW LABELS MISSING. ASSIGNABLE CAUSE WAS DETERMINED TO BE AN EXTERNAL INFLUENCE. MISSING, BROKEN,DAMAGED OR CRACKED DIRECTION OF FLOW LABEL WOULD BE CONSIDERED A RISK TO PATIENT SAFETY. THE LABEL SERVES DUAL FUNCTIONALITY. ONE REASON FOR IT TO BE THERE IS TO ASSIST THE CLINICIAN IN THE PROPER DIRECTION THE TUBING SHOULD BE LOADING AND IS A MITIGATION FOR INCORRECT SET LOADING. IT IS ALSO USED AS A SHIM AND IS DIFFERENT ON EVERY DEVICE. DEPENDING ON HOW THE DOOR CLOSES AND HOW IT IS CALIBRATED IS BASED ON THE SIZE OF THE SHIM. THE ABSENCE OR DAMAGE OF THIS LABEL/SHIM COULD PUT THE PATIENT AT RISK BY POSSIBLY EXPOSING THEM TO AN INCORRECT SET LOAD AND INCORRECT CALIBRATION. ALTHOUGH THE CUSTOMER REPORTED NO PATIENT INVOLVEMENT, THE POTENTIAL HAZARDOUS SITUATION RELATED TO THIS EVENT WOULD BE FLOW RATE INACCURACY > 10%. DIRECTION OF FLOW LABELS WERE REPLACED AND CALIBRATED DURING THE REPAIR PROCESS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP HAD MISSING DOOR SHIMS. IT WAS ALSO REPORTED THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    703124 SPECTRUM INFUSION PUMP INFUSION PUMP FRN BAXTER HEALTHCARE CORPORATION 35700

    Patients

    Seq Age Sex Outcome Treatment
    1