BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 10723380 · Received October 22, 2020

    Report

    Report Number
    2016493-2020-25751
    Event Type
    Malfunction
    Date Received
    October 22, 2020
    Report Date
    August 9, 2016
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K023264
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORTED EVENT AND SUBSEQUENT REPAIRS WERE INVESTIGATED THROUGH THE SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACKWISE FILES, AND FOUND RELEVANT TO THE SERVICE REPAIR. 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 RETURNED FOR SERVICE. THE DATABASE SHOWED NO QUALITY NOTIFICATIONS WERE OPENED FOR THE DEVICE. 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, 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. CAPA REFERENCE: (B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    ON 08/09/2016, AT 07:09:26; (B)(4). CONTACT (B)(6). ON 08/23/2016, AT 06:00:05; (B)(4). STATION 45 TOOLS USED EQ 103106; EQ 102890; EQ 102782. UNIT RECEIVED WITH: IUIS CONTAMINATED, HANDLE CRACKED, FRONT CASE CRACKED TOP LEFT, REAR CASE CRACKED BOTTOM LEFT REAR SCREW MOUNT, CLAW STICKS OPEN. ON 01/05/2017, AT 14:03:54; (B)(4). UPDATED FROM RCL TO MNR FOR THE MINOR REPAIR NEEDED PER GABRIEL LOPES, SERVICE TECH. REPAIR APPROVED BY WILHELM SEDLER, BIOMED DIRECTOR, AT (B)(4) FOR $(B)(6) (55% DISCOUNT APPROVED BY (B)(4), BD SERVICE CONTRACTS). NEW PO# IS (B)(6). NPI HAS BEEN CONFIRMED BY (B)(4), BD SALES REP, AT (B)(4) WITH THE CUSTOMER. ON 01/13/2017, AT 09:16:40; (B)(4). (B)(4). ON 03/13/2018, AT 10:49:48; (B)(4). 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, PER (B)(4). THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, PER (B)(4), 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, PER (B)(4), WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW, ALSO PER (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1181580 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1