BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDSYTEM III INFUSION PUMP

    MDR report key: 12251402 · Received July 30, 2021

    Report

    Report Number
    2016493-2021-511354
    Event Type
    Malfunction
    Date Received
    July 30, 2021
    Report Date
    December 7, 2018
    Manufacturer
    CAREFUSION SD
    Product Code
    FRN
    PMA / PMN Number
    K933545
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, 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 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 WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    THERE WAS NO PATIENT INVOLVEMENTFAILS CALIBRATION (SEE BELOW12/07/2018 08:48:52 SHALISA LORENZO (SLORENZO)PO FOR $779 APPROVED BY GARRETT YOUNG, 843-963-6540, [email protected]. SHIPPING & BILLING ADDRESSES CONFIRMED. [FOR CREDIT CARD PAYMENT PLEASE CONTACT: GREGORY GLYNN (843)963-6759]*FLUID SIDE OCCLUSION CALIBRATION STEP 2 FAILED ON PUMP B WITH A LOAD OF 159.76. BOTH BATTERIES WITH NEW CHANNEL B PUMP INSTALLED.12/17/2018 05:53:01 TONY THONG D NGUYEN (TTNGUYEN)PHYSICAL DAMAGE. CUSTOMER STATED CHANNEL B FAILED FSOD STEP 2 WAS CONFIRMED DUE TO A BROKEN DRIVE MODULE. ALSO FOUND DAMAGED CASE AT FRONT, BROKEN POLE CLAMP, BROKEN SIDE BOARD. AWAITING FOR CUSTOMER'S APPROVAL WITH MAJOR REPAIRCREDIT CARD NUMBERS PLEASE.12/28/2018 06:11:56 LAURYNE WASAN (LWASAN)PLEASE PROCEED WITH REPAIRS PER GREGG GLYNN AT 843.963.6759 FOR $779. PLEASE CHARGE REPAIR TO CUSTOMER'S CREDIT CARD:MC // -E803-5389-5AF78HDRP0W76D // EXP 08.23 GREGORY GLYNN01/03/2019 09:34:59 TONY THONG D NGUYEN (TTNGUYEN)FOUND DAMAGED NICAD BATTERY. REPLACED IT A NEW NICAD BATTERY.01/03/2019 11:20:15 ANNETTE A MENDEZ (AMENDEZ)1001901780490002940400458353530406

    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 WAS PERFORMED FROM THE DATE OF MANUFACTURE TO THE DATE OF PRODUCT RELEASE FOR DISTRIBUTION WHICH CONFIRMED THAT THIS DEVICE WAS NOT INVOLVED IN A PRODUCTION FAILURE WHICH CORRELATES TO THE CUSTOMER REPORTED ISSUE. A REVIEW OF THE COMPLAINT HISTORY WAS PERFORMED WHICH DID NOT CONFIRM SIMILAR COMPLAINTS WITH THE SAME OR RELATED FAILURE MODE. THE CUSTOMER STATED THAT THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 1

    THERE WAS NO PATIENT INVOLVEMENT. (B)(6).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1151207 MEDSYTEM III INFUSION PUMP PUMP, INFUSION FRN CAREFUSION SD 2865

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown