BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8100 ALARIS PUMP MODULE

    MDR report key: 10598628 · Received September 29, 2020

    Report

    Report Number
    2016493-2020-13815
    Event Type
    Malfunction
    Date Received
    September 29, 2020
    Report Date
    March 30, 2016
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Removal / Correction Number
    Z-1768-2019
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    WONT CALIBRATE CASE REAR- DAMAGED/CRACKED, IUI- CONTAMINATION, AIL SENSOR ASSEMBLY- DAMAGED/CRACKED, BEZEL ASSEMBLY- DAMAGE - UNSPECIFIED, DOOR LATCH ASSEMBLY- SEAR- BENT THERE WAS NO PATIENT INVOLVEMENT. 03/30/2016 12:32:27 JEFFREY PAULICK (JPAULICK) PO FOR $329 APPROVED BY BOB HEATH, 405-608-3433, [email protected]. SHIPPING & BILLING ADDRESSES CONFIRMED. 04/19/2016 06:38:12 LIEN N TRAN (LTRAN) EST-MNR TO MJR 04/29/2016 14:24:33 JESSICA GALANG (JGALANG) UPDATED FROM MNR TO MJR FOR THE MAJOR REPAIR NEEDED PER LIEN TRAN, SERVICE TECH. REPAIR APPROVED BY BOB HEATH AT [email protected] FOR $365. NO CHANGE TO THE PO#. 05/03/2016 05:11:59 ANNETTE A MENDEZ (AMENDEZ) 1Z9791540272079532 02/01/2018 06:53:51 JOSEPH KUHLS (JKUHLS). FILE REOPENED TO ADD TRACK WISE PR NUMBER TO THE DEVICE DATA FIELD. 02/01/2018 07:51:48 JOSEPH KUHLS (JKUHLS). THE ORIGINAL REPORTED PROBLEM CODE WAS FOUND TO BE INCORRECT AFTER REVIEW OF THIS FILE. IT WAS DETERMINED THE ORIGINAL CODE SHOULD HAVE BEEN FPMT BASED ON THE CUSTOMERS REPORTED PROBLEM.

    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 DEVICE SERVICE HISTORY RECORD WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE PRESENT DATE. THIS DEVICE WAS 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 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). THE ORIGINAL REPORTED PROBLEM CODE WAS FOUND TO BE INCORRECT AFTER REVIEW OF THIS FILE. IT WAS DETERMINED THE ORIGINAL CODE SHOULD HAVE BEEN FPMT BASED ON THE CUSTOMERS REPORTED PROBLEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1064314 8100 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION SD 8100

    Patients

    Seq Age Sex Outcome Treatment
    1