BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 12187751 · Received July 19, 2021

    Report

    Report Number
    2016493-2021-509954
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Report Date
    October 2, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1360-2020
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS PREVIOUSLY RETURNED FOR SERVICE UNRELATED TO THE COMPLAINT OR SERVICE HISTORY. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF 24DEC2012. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(6) WAS PERFORMED IN BD2 TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE.

    Description of Event or Problem · 0

    PROBLEM DESCRIPTION (B)(6) 2018 06:09:12 (B)(6). (B)(6). (B)(6). SPEC, CUSTOMER ADVOCACY. COMPLAINT MANAGEMENT. PROBLEM DESCRIPTION: ON (B)(6) 2018 13:13:49 (B)(6). SN (B)(6). 8100 13-1033-149 ERROR. RECOMMEND TO REFLASH THE SOFTWARE. IF SOFTWARE FAILS, REPLACE LOGIC BOARD. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. SOFT FAULT- 13 1033 149.

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE TSC TROUBLESHOOTING PROCESS. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. THE DEVICE WAS PREVIOUSLY RETURNED FOR SERVICE UNRELATED TO THE COMPLAINT OR SERVICE HISTORY. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. A REVIEW OF THE DEVICE HISTORY RECORD SHOWED THE DEVICE HAD A MANUFACTURE DATE OF (B)(6) 2012. THE REVIEW WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY FOR SN (B)(4) WAS PERFORMED IN TRACKWISE WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE: (B)(4). DEVICE WAS NOT RETURNED TO MANUFACTURING FACILITY.

    Description of Event or Problem · 1

    (B)(4). (B)(6). SPEC, CUSTOMER ADVOCACY. COMPLAINT MANAGEMENT. (B)(4). SN (B)(4). 8100 13-1033-149 ERROR. RECOMMEND TO REFLASH THE SOFTWARE. IF SOFTWARE FAILS, REPLACE LOGIC BOARD. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT. SOFT FAULT- 13 1033 149.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1089900 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown