BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 19891126 · Received August 2, 2024

    Report

    Report Number
    2249723-2024-03112
    Event Type
    Malfunction
    Date Received
    August 2, 2024
    Report Date
    May 14, 2025
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MD, 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

    PROVIDING UPDATED DEVICE IDENTIFICATION INFORMATION IN ALIGNMENT WITH GUDID.

    Additional Manufacturer Narrative · 0

    UPDATED FIELD: B4, D8, D9, (G1(CONTACT OFFICE, CONTACT PERSON ¿ MFG SITE), G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES, INVESTIGATION CONCLUSIONS), H11. THE LOCAL GETINGE TRAINED BIOMED TESTED THE SUBJECT UNIT WITH CATHETER AND TRAINER WITHOUT ISSUE. OTHER THAN THE AFOREMENTIONED, UNIT WORKING AS INTENDED. A GETINGE FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED TO EVALUATE THE UNIT. FSE SUCCESSFULLY COMPLETED A SIMULATED TREATMENT ON UNIT WITH TESTING CATHETER AND TRAINER WITHOUT ISSUE, UPON INITIAL TESTING. IDENTIFIED SOIL INSIDE SAFETY DISK MEMBRANE, WHICH MAY CORRELATE WITH THE ALL MANIFOLD, MEMBRANE TEST FAILURE. IDENTIFIED SOIL INSIDE THE DRIVE MANIFOLD, VACUUM LINE, THROUGH DUCT GOING INTO THE VACUUM RESERVOIR. PRESSURE SIDE OF DRIVE MANIFOLD SIDE CLEAN. VACUUM RESERVOIR CLEAN. REPLACED SAFETY DISK AND DRIVE MANIFOLD AS A PRECAUTION. CLEAN DUCT BETWEEN DRIVE MANIFOLD, VACUUM SIDE, INTO THE VACUUM RESERVOIR. NOTHING UNUSUAL IDENTIFIED IN THE LOGS, ATTACHED FOR REFERENCE. POST REPLACING AFOREMENTIONED PARTS, SUCCESSFULLY COMPLETED A FULL FUNCTION CHECK WITHOUT ISSUE. UNIT CALIBRATED AND VERIFIED PER MANUFACTURING RECOMMENDATIONS. PARTS WILL BE RETURNED FOR COMPLAINT ANALYSIS.THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PN 0104-00-0031 REV. B, SN (B)(6) PN 0202-00-0140 REV. K, SN (B)(6) PARTS WERE RECEIVED WITH A REPORTED FAILURE OF AN AUTOFILL FAILURE. FAILS ALL MANIFOLD AND PIM TEST. ALSO IDENTIFIED SOIL INSIDE PARTS. THE FAT PERFORMED A VISUAL INSPECTION AND FOUND THE PARTS TO BE IN GOOD CONDITION. THE FAT INSTALLED PN 0104-00-0031 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER (B)(6) REVISION R. NO FAILURE CONFIRMED. THE FAT INSTALLED PN 0202-00-0140 IN CARDIOSAVE TEST FIXTURE SERIAL NUMBER (B)(6) AND TESTED THE PART TO FACTORY SPECIFICATIONS PER THE CARDIOSAVE SERVICE MANUAL PART NUMBER 0070-00-0639 REVISION R. NO FAILURE CONFIRMED.RETAINING THE PARTS IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING IN HOUSE MAINTENANCE DAILY CHECKS, THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) WAS IDENTIFIED AS FAILING THE PIM LEAK TEST. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    885444 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown