BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 11075969 · Received December 28, 2020

    Report

    Report Number
    2016493-2020-82323
    Event Type
    Malfunction
    Date Received
    December 28, 2020
    Report Date
    July 31, 2019
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    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 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 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 MOTOR STALL RECALL FEB 2013 - DOM- 07/31/2019 10:36:33 DWAYNE DAVIDS (DDAVIDS) BIOMED CONTACT JIM LISKA 860-710-3567 [email protected] 10/12/2019 09:09:38 DUNG V NGUYEN (DNGUYEN) EST RCL TO MNR 11/04/2019 06:55:56 LAURYNE WASAN (LWASAN) MINOR REPAIRS NEEDED PER DUNG NGUYEN, SERVICE TECH, DUE TO NON-ALARIS DOOR LATCH ASSEMBLU AND CORRODED IUI CONNECTORS. REPAIR DECLINED BY DAVID GEORGE, BIOMED, AT [email protected] AS HE STATED THE REPAIRS WOULD BE COMPLETED ON SITE. PLEASE ONLY COMPLETE THE RECALL. 11/04/2019 11:31:35 DUNG V NGUYEN (DNGUYEN) LVP MOTOR STALL RECALL COMPLETED. RETURN UNREPAIR DOOR LATCH ASSY THIRD PARTY PART. 11/04/2019 13:52:39 CHRISTINA CASTANEDA (CHCASTAN) 1001901720620000632000132721478129 11/16/2019 10:15:08 JOSHUA MONK (JMONK) 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
    1543252 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1