BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 10520515 · Received September 11, 2020

    Report

    Report Number
    2016493-2020-04757
    Event Type
    Malfunction
    Date Received
    September 11, 2020
    Report Date
    January 2, 2018
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K032233
    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 SERVICE REPAIR PROCESS. FAILURE DATA AND PARTS-USED INFORMATION WERE REVIEWED FOR THE SAP AND TRACKWISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. NO IDENTIFIED ISSUES REQUIRED ESCALATION. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE. THE DEVICE WAS NOT PREVIOUSLY 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)(6) WAS PERFORMED WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE AND RETURNED FOR THE SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF COMPLAINT HISTORY RECORD IN TRACKWISE WAS PERFORMED FOR THE SN (B)(6) WHICH CONFIRMED THAT 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 · 0

    CASE FRONT-CRACK, CASE REAR-CRACK, BARREL CLAMP ASSEMBLY-CRACK, HANDLE-CRACK, MODULE LATCH-CRACK, LABEL-DAMAGED, FLANGE GRIPPER-CRACK, IUI-CORROSION, CARRIAGE ASSEMBLY -SPLIT NUT WORN AND DOOR ASSEMBLY-LIGHT DAMAGE. 01/02/2018 11:12:09 RFC_REPAIRS (RFC_REPAIRS) PO FOR $529. 01/22/2018 06:02:49 MARITES MALIG (MMALIG) PHONE 858-458-7000 7000 WAITING FOR CCRD INFO. 02/12/2018 10:24:13 (B)(6) UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIR NEEDED PER MARITES MALIG, SERVICE TECH. REPAIR APPROVED BY (B)(6) FOR $529. NEW PO# IS 818-0626. REPAIR WILL BE BILLED TO PO AND NOT CREDIT CARD PER CHRIS. (B)(6) 2018 08:26:51 (B)(6) A MENDEZ (AMENDEZ) (B)(4).

    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. NO IDENTIFIED ISSUES REQUIRED ESCALATION. A REVIEW OF THE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE. THE DEVICE WAS NOT PREVIOUSLY 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 RETURNED FOR THE SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF COMPLAINT HISTORY RECORD IN TRACKWISE WAS PERFORMED FOR THE SN (B)(4) WHICH CONFIRMED THAT 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    984022 8120 ALARIS PCA PUMP,INFUSION FRN CAREFUSION 8120

    Patients

    Seq Age Sex Outcome Treatment
    1