BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8015 ALARIS SYSTEM PC UNIT

    MDR report key: 11139446 · Received January 8, 2021

    Report

    Report Number
    2016493-2021-04115
    Event Type
    Malfunction
    Date Received
    January 8, 2021
    Report Date
    February 6, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403801518
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORTED PROBLEM WAS CONFIRMED. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE, AND PRODUCT WAS NOT RETURNED FOR SERVICING WHICH NOT CORRELATES TO THE CUSTOMER REPORTED ISSUE. A TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED, AND IT WAS CONFIRMED THAT THERE WERE ADDITIONAL COMPLAINTS RECEIVED WITH SIMILAR SN (B)(4) FOR THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    BD QUALITY ADVOCATE, THIS NOTIFICATION IS TO INFORM YOU THAT A NEW CASE HAS BEEN CREATED WITH THE COMPLAINT TYPE CATEGORY INFUSION CA. CASE #: 00986123 CASE SUBJECT: NPI 8015 ERROR CODE 121.2070 ACCOUNT NAME: COASTAL CAROLINA MEDICAL CENTER ACCOUNT #: 10054215 ASSET NAME: 8015LS PCU DOM V9.19.1.2 A/B/G ASSET LOCATION: CONTACT: RYAN LAZIER CONTACT EMAIL: [email protected] CONTACT PHONE: 843-784-8162 CONTACT MOBILE: PATIENT OR USER INVOLVEMENT: NO PATIENT OR USER HARM: NO CASE DESCRIPTION: CUSTOMER REPORTS ERROR CODE 121.2070 ON THEIR 8015 (SN: (B)(4)). FAILURE DEVICE TYPE: FAILURE PROBLEM TYPE: FAILURE MODE: CASE RESOLUTION: INFORMED CUSTOMER THIS IS MOST LIKELY DUE TO THE POWER SUPPLY BOARD, THE 120V SWITCHING POWER SUPPLY, OR BOTH. RECOMMENDED SENDING IN FOR REPAIR. EMAILED OUR FIXED LEVEL PRICING LIST. CUSTOMER WILL CALL BACK WITH PO. ENDED CALL. REF:_00D30Y0YR._5000L1QKUJJ:REF

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    34788 8015 ALARIS SYSTEM PC UNIT PUMP, INFUSION FRN CAREFUSION SD 8015 10885403801518

    Patients

    Seq Age Sex Outcome Treatment
    1