BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11144646 · Received January 10, 2021

    Report

    Report Number
    2016493-2021-04001
    Event Type
    Malfunction
    Date Received
    January 10, 2021
    Report Date
    February 1, 2020
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403810015
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL REPAIRS OUTSIDE THE RECALL REPAIR WERE ADDRESSED. THE DEVICE WAS REPAIRED, RETESTED, AND RELEASED BACK TO THE CUSTOMER. 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 RETURNED FOR SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    LVP BEZEL POST RECALL 2017- 04/09/2019 13:28:40 SANDRA J MCDONALD (SMCDONAL) LVP BEZEL POST RECALL 2017 UNIT TO BE SENT BACK TO SISTER FACILITY BON SECOURS PER EVAN ACAR, BD TECH WHO IS AT THE ACCOUNT TODAY. KRIS BURLESON - BIOMED 843-870-8374 [email protected] 04/29/2019 08:34:43 THONG TRANG (TTRANG) ESTIMATE MJR WAITING FOR APPROVAL. 05/28/2019 13:49:01 CRISLEIVY PENA (CRPENA) MAJOR REPAIR NEEDED PER THONG TRANG, SERVICE TECH, DUE TO LOWER PRESSURE SENSOR (NON-ALARIS/UNSUPPORTED PART) AND CORRODED REAR CASE . REPAIR DECLINED BY KRISTOFFER BURLESON, BIOMEDICAL TECHNICIAN, AT [email protected]. UNIT WILL BE RETURN UNREPAIRED. PLEASE REFERENCE RMA 301342364 FOR A COPY OF THE ESTIMATE / CUSTOMER RESPONSE. PLEASE PERFORM THE RECALL UPDATE ONLY PER THE CUSTOMER'S REQUEST. 06/07/2019 14:35:54 THONG TRANG (TTRANG) LVP BEZEL POST RECALL COMPLETED REPLACED BEZEL ASSEMBLY. 06/11/2019 06:21:46 ANNETTE A MENDEZ (AMENDEZ) 1001901751670002941400102839880084 02/01/2020 11:02:14 JOSHUA MONK (JMONK) DURING THE REPAIR PROCESS, IT WAS DETERMINED THAT THE ORIGINAL PROBLEM CODE SHOULD HAVE BEEN BROK (BROKEN DAMAGED) FOR COMPLAINT TRENDING PURPOSES FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. THIS FILE WAS INITIALLY CLASSIFIED AS A LEVEL 3 NON-COMPLAINT FOR PREVENTATIVE MAINTENANCE, UPGRADE, RECONDITIONING, CUSTOMER INQUIRY, OR RECALL WHICH DO NOT REQUIRE CUSTOMER ADVOCACY QUALITY REVIEW OR A NO PATIENT INVOLVED STATEMENT. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, AND/OR REPAIRS (WHICH MAY OR MAY NOT HAVE BEEN PERFORMED) THAT ARE OUT-OF-SCOPE WITH THE INITIAL LEVEL 3 NON-COMPLAINT. SUCH DOCUMENTATION UPGRADED THE FILE TO A LEVEL 2 COMPLAINT, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    40757 8100 ALARIS PUMP MODULE PUMP,INFUSION FRN CAREFUSION SD 8100 10885403810015

    Patients

    Seq Age Sex Outcome Treatment
    1