BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 10786928 · Received November 4, 2020

    Report

    Report Number
    2016493-2020-32514
    Event Type
    Malfunction
    Date Received
    November 4, 2020
    Report Date
    August 4, 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 · 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. 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 PREVIOUSLY RETURNED FOR SERVICE UNRELATED TO THE 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 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 THAT THIS DEVICE WAS INVOLVED IN A SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(6). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    ON 08/04/2016 17:14:56 (B)(6). ON 08/04/2016 17:14:57 (B)(6). FOR ADDITIONAL REPAIRS PLEASE CONTACT (B)(6), BIOMED SPECIALIST, (B)(6). ON 08/26/2016 06:29:45 (B)(6). EST - RCL TO MNR, PRP - 13AUG2017. FRONT CASE CRACKED TOP LEFT, REAR CASE CRACKED BOTTOM LEFT AT MOUNTING POINT, BOTH HANDLES CRACKED, AND BARREL CLAMP CRACKED. NPI HAS BEEN CONFIRMED BY (B)(6), BD SALES REP, AT (B)(6) WITH THE CUSTOMER. ON 01/23/2017 12:55:08 (B)(6). (B)(4). ON 03/28/2018 08:33:03 (B)(6). 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 SWI (B)(4). THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, PER (B)(4) AND (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) AND (B)(4), WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW, ALSO PER SWI (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. 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 PREVIOUSLY RETURNED FOR SERVICE UNRELATED TO THE 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 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 THAT THIS DEVICE WAS INVOLVED IN A SERVICING FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. THE TRACKWISE COMPLAINT HISTORY REVIEW WAS COMPLETED AND IT WAS CONFIRMED THAT MULTIPLE COMPLAINTS WERE RECEIVED WITH SIMILAR SN (B)(4). WE WILL CONTINUE TO MONITOR ALL COMPLAINTS AND FAILURE MODES FOR UPWARD TRENDING AND TAKE APPROPRIATE ACTION AS REQUIRED. CAPA REFERENCE:(B)(4). THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    (B)(4). FRONT CASE CRACKED TOP LEFT, REAR CASE CRACKED BOTTOM LEFT AT MOUNTING POINT, BOTH HANDLES CRACKED, AND BARREL CLAMP CRACKED. (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
    1249608 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Other