BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID, TYPE B PLUG

    MDR report key: 12738053 · Received November 2, 2021

    Report

    Report Number
    2249723-2021-02530
    Event Type
    Malfunction
    Date Received
    November 2, 2021
    Date of Event
    October 12, 2021
    Report Date
    June 13, 2024
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Removal / Correction Number
    N/A
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    EVENT SITE STATE AND POSTAL CODE: (B)(6). IT WAS REPORTED THAT DURING USE ON A PATIENT, AN ALARM SOUNDED AND THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUTDOWN WHILE USING THE WARD. THERE WAS NO PATIENT HARM/INJURY AND NO ADVERSE EVENT REPORTED. THIS IABP UNIT WAS INSPECTED AT OUR SERVICE CENTER AFTER RETURNING FROM THE FACILITY. ALTHOUGH SYSTEM FUNCTIONAL CHECK AND RUNNING TEST ARE BEING PERFORMED, ALTHOUGH RUNNING TEST WAS PERFORMED WITH SYSTEM TRAINER AND TEST BALLOON, THE ISSUE WAS NOT ABLE TO BE REPLICATED. THE FOLLOWING PARTS: BACKPLANE BOARD, EXECUTIVE PROCESSOR BOARD, VIDEO GENERATOR BOARD, COIL CABLE AND COIL CORD WERE REPLACED AS A PRECAUTIONARY MEASURE. AFTER REPLACING OF THE PARTS, RUNNING TEST WAS PERFORMED AGAIN FOR 13 DAYS NORMALLY. THEN PREVENTIVE MAINTENANCE WAS PERFORMED AS PER FACTORY SPECIFICATION.THE NRC RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER: 0670-00-0768, 0670-00-0770, 0012-00-1796, 0012-00-1801, 0040-00-0456(KIT) IS MADE UP FOR FOLLOWING PARTS: 0670-00-0781, 0670-00-0841. THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF DISPLAY BLACKED OUT AND ERROR CODE# 111 & 118. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND FOUND PART NUMBER: 0012-00-1801 BROKEN GREY WIRE BY CONNECTOR SIDE, AND THE OTHER PARTS LOOKS TO BE IN GOOD CONDITIONS. DUE TO THIS DAMAGE PART AND THE RISK, THIS PART 0012-00-1801 CANNOT BE INVESTIGATED ANY FURTHER BY THE NRC. INSTALLED THE BELOW FOLLOWING PARTS TOGETHER INTO THE CARDIOSAVE AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION P. THE NRC COULD NOT VERIFY THE FAILURE OF BLACKED OUT DISPLAY AND ERRORS# 111 AND 118. THE ALL PARTS PASSED TESTING. RETAINING THE FOLLOWING PARTS IN THE NRC AS PER PROCEDURE NUMBER (B)(4) REV AJ. THE NEW SUPPLIER (B)(4), WILL NO LONGER ACCEPT (B)(4) BOARDS BACK FOR FAILURE ANALYSIS. FURTHER FAILURE ANALYSIS IS NOT POSSIBLE. THE BOARD WILL BE SCRAPPED PER PROCEDURE NUMBER (B)(4) REV.AL. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 0

    A GETINGE FIELD SERVICE ENGINEER (FSE) WAS INSPECTED AT OUR SERVICE CENTER AFTER RETURNING FROM THE FACILITY. ALTHOUGH SYSTEM FUNCTIONAL CHECK AND RUNNING TEST ARE BEING PERFORMED, ALTHOUGH RUNNING TEST WAS PERFORMED WITH SYSTEM TRAINER AND TEST BALLOON, THE ISSUE WAS NOT ABLE TO BE REPLICATED. THE FOLLOWING PARTS: BACKPLANE BOARD, EXECUTIVE PROCESSOR BOARD, VIDEO GENERATOR BOARD, COIL CABLE AND COIL CORD WERE REPLACED AS A PRECAUTIONARY MEASURE. AFTER REPLACING OF THE PARTS, RUNNING TEST WAS PERFORMED AGAIN FOR 13 DAYS NORMALLY. THEN PREVENTIVE MAINTENANCE WAS PERFORMED AS PER FACTORY SPECIFICATION. THE DEFECTIVE COMPONENTS WERE RECEIVED FOR FURTHER INVESTIGATION. THE NRC RECEIVED THE PART NUMBER: 0670-00-0768 SERIAL NUMBER: (B)(6) 34_SWEMCO, PART NUMBER: 0670-00-0770 SERIAL NUMBER: (B)(6), PART NUMBER: 0012-00-1796 SERIAL NUMBER: N/A, PART NUMBER: 0012-00-1801 SERIAL NUMBER: N/A AND PART NUMBER:0040-00-0456(KIT) IS MADE UP FOR FOLLOWING PARTS: PART NUMBER: 0670-00-0781 SERIAL NUMBER: (B)(6) AND PART NUMBER: 0670-00-0841 SERIAL NUMBER: (B)(6). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF DISPLAY BLACKED OUT AND ERROR CODE# 111 & 118. PERFORMED VISUAL INSPECTION OF ALL PARTS RECEIVED AND FOUND PART NUMBER: 0012-00-1801 BROKEN GREY WIRE BY CONNECTOR SIDE, AND THE OTHER PARTS LOOKS TO BE IN GOOD CONDITIONS. DUE TO THIS DAMAGE PART AND THE RISK, THIS PART 0012-00-1801 CANNOT BE INVESTIGATED ANY FURTHER BY THE NRC. INSTALLED THE BELOW FOLLOWING PARTS TOGETHER INTO THE CARDIOSAVE TEST FIXTURE SN (B)(6) AND TESTED TO THE FACTORY SPECIFICATIONS PER PN 0002-07-D016 REVISION C AND THE CARDIOSAVE SERVICE MANUAL PN 0070-00-0639 REVISION P. PART NUMBER: 0670-00-0768 SERIAL NUMBER: (B)(6) PART NUMBER: 0670-00-0770 SERIAL NUMBER: (B)(6) PART NUMBER: 0012-00-1796 SERIAL NUMBER: N/A AND PART NUMBER:0040-00-0456(KIT). THE NRC COULD NOT VERIFY THE FAILURE OF BLACKED OUT DISPLAY AND ERRORS# 111 AND 118. THE ALL PARTS PASSED TESTING. RETAINING THE FOLLOWING PARTS IN THE NRC AS PER PROCEDURE NUMBER 0002-07-D008 REV AJ. PART NUMBER: 0012-00-1796 SERIAL NUMBER: N/A PART NUMBER: 0012-00-1801 SERIAL NUMBER: N/A. 0670-00-0841-THE NEW SUPPLIER (B)(4), WILL NO LONGER ACCEPT SWEMCO BOARDS BACK FOR FAILURE ANALYSIS. FURTHER FAILURE ANALYSIS IS NOT POSSIBLE. THE BOARD WILL BE SCRAPPED PER PROCEDURE NUMBER 0002-07-D008 REV.AL. DUE TO OLD PART NUMBER AND NON-ROHS PART NUMBER, THE SUPPLIER WILL NO LONGER ACCEPT FOLLOWING BOARDS FOR FURTHER ANALYSIS. RETAINING BOARDS IN THE NRC DEPT. PER PROCEDURE 0002-07-D008 REV AL. PART NUMBER: 0670-00-0768 SERIAL NUMBER: (B)(6) AND PART NUMBER: 0670-00-0781 SERIAL NUMBER: (B)(6) THE FAT DEPT. RECEIVED PART NUMBER 0670-00-0770 EXEC. PROCESSOR BOARD SERIAL NUMBER (B)(6) FROM THE SUPPLIER. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION AND FOUND THE PART TO BE IN GOOD CONDITION. SKIP ICT AND HI-POT TESTING PROCESS (SINCE THE DATE CODES OF T1 AND T3 ARE LESS THAN 1502). ONLY FCT AND MANUAL TESTS ARE PERFORMED AND PASSED. PLEASE SEE ATTACHED INVESTIGATION DOCUMENT RECEIVED FROM SUPPLIER. RETAINING THIS BOARD IN THE FAT DEPT. PER PROCEDURE 0002-07-D008 REV AQ. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE NOT CONFIRMED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS NOT CONFIRMED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION IS BEING REQUESTED WITH REGARD TO THE REPAIR AND STATUS OF THE IABP. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THIS INFORMATION IS PROVIDED TO US. UNIT NOT AVAILABLE FOR TESTING.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING USE ON A PATIENT, AN ALARM SOUNDED AND THE CARDIOSAVE INTRA-AORTIC BALLOON PUMP (IABP) SHUTDOWN WHILE USING THE WARD. THE USER INFORMED THAT RESTARTED THE UNIT WITH OUT ANY PROBLEM AND WAS ABLE TO CONTINUE WITH THERAPY. THERE WAS NO PATIENT HARM/INJURY AND NO ADVERSE EVENT REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1636489 CARDIOSAVE HYBRID, TYPE B PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 N/A 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Prefer Not To Disclose