BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    8110 ALARIS SYRINGE PUMP

    MDR report key: 11291128 · Received February 8, 2021

    Report

    Report Number
    2016493-2021-24163
    Event Type
    Malfunction
    Date Received
    February 8, 2021
    Report Date
    November 30, 2017
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K133532
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    003

    Narratives

    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 DATE CORRESPONDING TO THIS SERVICE NOTIFICATION NUMBER. 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 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 TWO RECALL 2016- 11/30/2017 06:46:18 CONNIE CHALKE (CCHALKE) RECALL CONTACT TONYA SANTIAGO 281-338-3991 [email protected] 12/12/2017 09:37:17 ALLEN WORTH (AWORTH) RECALL WORK PENDING RESPONSE TO (MJR) REPAIR ESTIMATE SUBMITTED 12/12, FOR THE FOLLOWING: FR: CR: TOP/LT/DOME, BEL/PRS/4X, TDH/TOP/LT&RT, D: BOT/4X, LT/3X, RT/3X. KP: D: LRG WIND. SCR: @PAUSE. RR: CR: LT& RT/FR/EDG, BOT/RT/MID/SCR, BASE/LT/FR/SCR; D: BOT/RT/FR/CNR. HND: CR: LT &RT@CASE/CNR, LT@SPINE, RT@INNR. MEC: B/C (CR). M/L: ACT/LS. IUI'S: OXI. G/R: CR: LT&RT@FR/SCR. T/D: BENT (LT). K/A: WEAK RET. E/L: 357.6020, 351.6740, 351.6660, 356.6710. TSTS: PRELIMS OK. PFA: PASS. PPA: PASS. ***UNIT REQUIRES SYR 8110 SPLIT NUT RECALL TWO 2016.*** ***CUSTOMER DOES NOT HAVE PRP COVERAGE FOR THIS MODEL.*** 01/26/2018 14:10:13 JESSICA GALANG (JGALANG) UPDATED FROM RCL TO MJR FOR THE MAJOR REPAIR NEEDED PER ALLEN WORTH, SERVICE TECH. REPAIR APPROVED BY TONYA SANTIAGO AT [email protected] FOR $579. PO# HAS BEEN UPDATED. NPI 03/12/2018 10:40:14 ALLEN WORTH (AWORTH) ==RECALLS: SYR 8110 SPLIT NUT RECALL 2 RECALL COMPLETE. ===REPAIR: KEYPAD: SCRATCHED/DENTED: LRG WINDOW, @"PAUSE": REPLACED KEYPAD ASSY. FRONT CASE: CRACKED: TOP/LT/DOME, BEL PRS HSNG/4X; TOP DISC HOLDER: TOP/LT&RT: REPLACED FRONT CASE AND TOP DISC HOLDER. REAR CASE: CRACKED: LT&RT/FR/EDG, BOT/RT/MID/SCR, BASE/LT/FR/SCR; DENTS: BOT/RT/FR/CNR: REPLACED REAR CASE. HANDLE: CRACKS: LT&RT@CASE/CNR, LT@SPINE, RT@INNR/RR: REPLACED CARRY HANDLE. BARREL CLAMP: CRACKED: REPLACED BARREL CLAMP, SEAL, & BUSHING. TUBE DRIVE: BENT (LEFT): REPLACED DRIVE TUBE, SLEEVE. GRIPPER-RETAINER: CRACKED: LT&RT/FR/SCR: REPLACED GRIPPER-RETAINER, FLANGE GRIPPER, SEAL, & GASKET. IUI'S: OXIDIZED CONTACTS: REPLACED BOTH IUI'S. MODULE LATCH: WORN ACTUATOR & LEAF SPRING: REPLACED. KNOB ACTUATOR: WEAK RETURN: FOUND INTERNAL KNOB ACTUATOR SHAFT & SUPPORTS VERY DIRTY. CLEANING REQUIRED. DID NOT REPLACE KNOB ACTUATOR. **ON DIS-ASSEMBLY FOUND SPLIT NUT ACTUATOR ROD NUT CORRODED TO SHAFT; ACTUATOR HEAD WAS STRIPPED. REPLACED ROD, NUT, AND ACTUATOR HEAD. INCIDENTAL REPAIR PARTS: 2 FEET, 2 LABELS, 1 MYLAR GASKET, 1 SENSOR FLAG LEAF SPRING. ===MAINTENANCE ACTIONS: CALIBRATION COMPLETED. P/M COMPLETED. ===TAMPER SEAL: VOID: MISSING. 03/13/2018 08:47:53 ARJIE ANCHETA (ARANCHET) 1Z9791540270552345 03/21/2019 08:25:55 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
    192382 8110 ALARIS SYRINGE PUMP PUMP, INFUSION FRN CAREFUSION SD 8110

    Patients

    Seq Age Sex Outcome Treatment
    1