BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11300079 · Received February 9, 2021

    Report

    Report Number
    2016493-2021-24479
    Event Type
    Malfunction
    Date Received
    February 9, 2021
    Report Date
    June 5, 2017
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    UDI-DI
    10885403424267
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORD IN SAP FOR SN (B)(4) WAS PERFORMED FROM THE DATE OF THE MANUFACTURE TO DATE OF THE RELEASE OF PRODUCT, 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. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    SYRINGE SPLIT NUT 2 RECALL FOR OPS LAB- 06/05/2017 12:24:11 WILLIAM BURDETTE (WBURDETT) PER MICHELLE CHEUNG, PLEASE FORWARD THIS DEVICE TO OPS LAB FOR INVESTIGATION. RECALL CONTACT MICHELLE BROWN, BIOMED, [email protected], 816-895-5188 DEVICE ALSO NEEDS SOFTWARE FLASH TO SW VERSION 9.15.1.2 08/22/2017 10:57:31 JAMES E THIBAULT (JTHIBAUL) THE EVENT AND ERROR LOGS WERE DOWNLOADED UPON RECEIPT. THE LOG FILES SHOWED 10 OCCURRENCES OF LOG ONLY ERRORS 353.7200.5 (POSITION SENSOR ERROR) FROM 10/11/2014 TO 7/9/2016. FROM 4/20 TO 5/15/2017, 7 354.6770.0 PRESSURE SENSOR CIRCUIT FAILURES OCCURRED AT POWER ON. MANUAL POWER CYCLING OF THIS SYR MODULE WITH A LAB PCU DID NOT RESULT IN ANY ERRORS. 08/22/2017 11:50:11 JAMES E THIBAULT (JTHIBAUL) THE SYR WAS THEN ATTACHED TO A LAB PCU AND 713 POWER CYCLES WERE COMPLETED BETWEEN 6/20 AND 8/21/2017 WITHOUT ERROR. PRESSURE WAS APPLIED TO PRESSURE DISK INSTALLED IN THE SYRINGE DURING POWER CYCLING - NO ERRORS OCCURRED. 12/04/2017 10:40:09 SAID S MORGAN (SSMORGAN) PHONE 8586172509 RAN UNIT MULTIPLE TIME FOR TWO DAYS, CANNOT DUPLICATE ERROR. RETURNED TO SERVICE DEPARTMENT. 12/04/2017 10:49:17 NAM HUU NGUYEN (NHNGUYEN) SET STATUS TO 90 FICM FAILURE INVESTIGATION COMPLETE PER SAID'S REQUEST. 01/30/2018 11:03:30 STEVEN WEAR (SWEAR) SEAL BROKEN. EST - RCL TO MJR FRONT CASE CRACKED UNDER PRESSURE SENSOR, REAR CASE CRACKED BOTTOM LEFT CORNER, AND IUIS CORRODED. 02/12/2018 09:28:15 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MNR FOR THE MINOR REPAIR NEEDED PER STEVE WEAR, SERVICE TECH. REPAIR APPROVED BY MICHELLE BROWN AT [email protected] FOR $579. NEW PO# IS 300368-SRV. NPI 02/19/2018 06:43:36 ANNETTE A MENDEZ (AMENDEZ) 1Z9791540171412219 01/11/2019 09:51:19 JOSEPH KUHLS (JKUHLS) 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 1501-006-000. THIS FILE CONTAINED DOCUMENTATION OF PRODUCT DEFICIENCY ALLEGATIONS, PER SWI-151-070-000 AND SWI 1501-096-000, 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 SWI 1501-070-000 AND SWI-096-000, WHICH REQUIRED A LEVEL 2 CUSTOMER ADVOCACY QUALITY REVIEW, ALSO PER SWI 1501-070-000.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    197920 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110 10885403424267

    Patients

    Seq Age Sex Outcome Treatment
    1