BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8120 ALARIS PCA

    MDR report key: 10579228 · Received September 24, 2020

    Report

    Report Number
    2016493-2020-10489
    Event Type
    Malfunction
    Date Received
    September 24, 2020
    Report Date
    January 22, 2018
    Manufacturer
    CAREFUSION SD
    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 TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE. THE DEVICE WAS PREVIOUSLY RETURNED FOR ISSUES UNRELATED TO THE REPORTED COMPLAINT OR SERVICE HISTORY. 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 PRODUCT WAS RETURNED FOR THE SERVICING WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY RECORD IN THE TRACKWISE WAS PERFORMED FOR THE SN (B)(6) WHICH CONFIRMED NO SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. CAPA REFERENCE:CA-2018-0171. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    FAULTY CONTROL/NEEDS CALIBRATION. CARRIAGE ASSY- DAMAGED/CRACKED, PCA HANDSET- HANDSET DAMAGE, BARREL CLAMP ASSY- DAMAGED/CRACKED, HANDLE- DAMAGED/CRACKED, CASE REAR- DAMAGED/CRACKED, CASE FRONT- DAMAGED/CRACKED, PCA DOOR- FRONT DOOR DAMAGED/CRACKED, PCA HANDSET- CORD DAMAGED, FLANGE GRIPPER- DAMAGED/CRACKED, CARRIAGE ASSY- TUBE DRIVE BENT, LABEL- DAMAGED, IUI- DAMAGE AND DOOR ASSY- DAMAGE- OTHER THERE WAS NO PATIENT INVOLVEMENT. 01/22/2018 12:40:25 (B)(6). PO FOR (B)(6) APPROVED BY (B)(6) . SHIPPING & BILLING ADDRESSES CONFIRMED. *CC INFO: (B)(6). 01/31/2018 11:32:01 (B)(6). WAITING FOR CREDIT CARD NFO. 02/19/2018 05:12:12 (B)(6). (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 TRACK WISE FILES AND FOUND RELEVANT TO THE SERVICE REPAIR. A REVIEW OF THE SOURCE DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE. THE DEVICE WAS PREVIOUSLY RETURNED FOR ISSUES UNRELATED TO THE REPORTED COMPLAINT OR SERVICE HISTORY. 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 THE 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

    (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1047375 8120 ALARIS PCA PUMP, INFUSION FRN CAREFUSION SD 8120

    Patients

    Seq Age Sex Outcome Treatment
    1