BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM

    MDR report key: 16471285 · Received March 2, 2023

    Report

    Report Number
    2249723-2023-01360
    Event Type
    Malfunction
    Date Received
    March 2, 2023
    Date of Event
    February 22, 2023
    Report Date
    March 12, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108704
    PMA / PMN Number
    K063525
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION.

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4,D9,E1(SITE COUNTRY),G3,G6,H2,H3,H4,H6(TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, INVESTIGATION CONCLUSIONS),H10,H11. CORRECTED FIELD: H6(HEALTH EFFECT ¿ CLINICAL CODE, HEALTH EFFECT ¿ IMPACT CODES). IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) HAD A SALINE INGRESS WHICH CAUSED CRM SCREWS TO SEIZE. THERE WAS NO PATIENT INVOLVEMENT AND NO HARM REPORTED. A GETINGE FIELD SERVICE ENGINEER (FSE) EVALUATED AND REPLACED (D997-00-0986-01) CRM, ASSEMBLY. THE FSE COMPLETED PM WITH FULL CALIBRATION. THE UNIT PASSED ALL FUNCTIONAL AND SAFETY TESTS TO FACTORY SPECIFICATIONS. THE UNIT WAS CLEARED FOR CLINICAL USE. FAT WAS ABLE TO VERIFY THE REPORTED ISSUE OF THE SALINE SPILL CAUSING THE CRM TO BE SEIZED TO THE SAFETY DISK. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AP.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE (PM) PERFORMED BY A GETINGE SERVICE TERRITORY MANAGER (STM) , THE CS300 INTRA-AORTIC BALLOON PUMP (IABP) UNIT SEIZED HARDWARE ON SAFETY DISK. THERE WAS NO PATIENT INVOLVEMENT.

    Description of Event or Problem · 0

    N/A.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    518186 CS300 INTRA-AORTIC BALLOON PUMP, REFURBISHED, ENGLISH,NON-UTS,DOM SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-UC-3023-53 10607567108704

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown N/A.