BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SPECTRUM INFUSION PUMP

    MDR report key: 11289392 · Received February 5, 2021

    Report

    Report Number
    1314492-2021-00227
    Event Type
    Malfunction
    Date Received
    February 5, 2021
    Date of Event
    January 14, 2021
    Report Date
    April 1, 2021
    Manufacturer
    BAXTER HEALTHCARE CORPORATION
    Product Code
    FRN
    UDI-DI
    00085412498683
    PMA / PMN Number
    K133801
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION H6: INVESTIGATION FINDINGS CODE IS UPDATED TO C0402.

    Additional Manufacturer Narrative · 0

    B5: "IT WAS REPORTED THAT A SPECTRUM PUMP NOTHING HAPPENED WHEN THE BUTTON ABOVE THE OK WAS PRESSED." SHOULD BE UPDATED OT "IT WAS REPORTED THAT THE KEYPAD WAS NOT RESPONDING, NOTHING HAPPENED ON A SPECTRUM PUMP WHEN THE BUTTON ABOVE THE OK WAS PRESSED.". H6: INVESTIGATION FINDINGS CODE 3221 HAS BEEN UPDATED TO A070911. H10: "THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE CUSTOMER REPORTED KEYHOLE CRACKED WHICH WAS REPRODUCED." SHOULD BE UPDATED TO "THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE KEYPAD NOT RESPONDING, NOTHING HAPPENED WHEN THE BUTTON ABOVE THE OK WAS PRESSED, WHICH WAS REPRODUCED." H6: TYPE OF INVESTIGATION CODE B11 WAS ADDED. H10: A SERVICE HISTORY REVIEW REVEALED NO INDICATION THAT THE PARTS REPLACED DURING SERVICING CAUSED OR CONTRIBUTED TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    BAXTER RECEIVED AND EVALUATED THE DEVICE. THE REPORTED CONDITION WAS VERIFIED. THE DEVICE WAS FOUND OUT OF SPECIFICATION IN RELATION TO THE CUSTOMER REPORTED KEYHOLE CRACKED WHICH WAS REPRODUCED. VISUAL INSPECTION FOUND EXTRA FORCE REQUIRED FOR OUTPUT OF THE THIRD SOFT KEY. THE KEYPAD WAS REPLACED TO CORRECT THIS CONDITION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A SPECTRUM PUMP NOTHING HAPPENED WHEN THE BUTTON ABOVE THE OK WAS PRESSED. THERE WAS NO PATIENT INVOLVEMENT. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    185968 SPECTRUM INFUSION PUMP PUMP, INFUSION FRN BAXTER HEALTHCARE CORPORATION NA NA 00085412498683

    Patients

    Seq Age Sex Outcome Treatment
    1