BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CARDIOSAVE HYBRID TYPE "B" PLUG

    MDR report key: 19708073 · Received July 10, 2024

    Report

    Report Number
    2249723-2024-02789
    Event Type
    Malfunction
    Date Received
    July 10, 2024
    Date of Event
    June 25, 2024
    Report Date
    January 20, 2025
    Manufacturer
    DATASCOPE CORP. - MAHWAH
    Product Code
    DSP
    UDI-DI
    10607567108391
    PMA / PMN Number
    K112372
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF OUR INVESTIGATION. ADDITIONAL CUSTOMER CONTACT PHONE: NAME: SAM RIVERA, OCCUPATION: BIOMEDICAL ENGINEER, PHONE: (B)(6).

    Additional Manufacturer Narrative · 0

    UPDATED FIELDS: B4, D8, D9, G1, G3, G6, H2, H3, H6 (TYPE OF INVESTIGATION, INVESTIGATION FINDINGS, COMPONENT CODES AND INVESTIGATION CONCLUSIONS), H11. CORRECTED FIELDS: D4 (UDI). DURING PM VISIT INSTALLATION OF PIM WAS MISALIGNED CAUSING FAILURE OF PIM, SOLENOID CONTROLLER AND POWER MANAGEMENT BOARD. FSE RESOLVED THE ISSUE BY REPLACING (D997-00-1178) PNEUMATIC MODULE ASSY (D670-00-1162) POWER MANAGEMENT AND (D670-00-1161) SOLENOID CONTROL. FSE COMPLETED FULL PM, CALIBRATED AND THEN TESTED THE SAFETY AND FUNCTIONALITY AS PER FACTORY SPECIFICATIONS AND IABP WAS THEN RETURNED TO CUSTOMER FOR CLINICAL USE. THE FAILURE ANALYSIS AND TESTING DEPT. RECEIVED THE FOLLOWING PARTS ASSOCIATED WITH THIS COMPLAINT: PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSEMBLY SERIAL NUMBER (B)(6). PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6). PART NUMBER 0670-00-1161 PCB, SOLENOID CONTROL SERIAL NUMBER (B)(6). THESE PARTS WERE RECEIVED WITH A REPORTED UNIT FAILURE OF A PIM INSTALLATION CAUSED POWER MANAGEMENT AND SOLENOID CONTROLLER FAILURE. THE FAILURE ANALYSIS AND TESTING DEPT. PERFORMED A VISUAL INSPECTION OF PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSEMBLY SERIAL NUMBER (B)(6) AND OBSERVED A PINCHED WIRE THAT APPEARS TO BE EXPOSED WHICH SHORTED TO THE METAL OF THE PIM. PART NUMBER 0670-00-1161 PCB, SOLENOID CONTROL SERIAL NUMBER (B)(6) HAS A SHORTED COMPONENT Q7 (BURNED), ALONG WITH COMPONENT CR62 THAT HAS BURN DAMAGE. PART NUMBER 0670-00-1162 PCB, POWER MANAGEMENT, ROHS SERIAL NUMBER (B)(6) APPEARS IN GOOD CONDITION, HOWEVER THE BOARD MIGHT HAVE BEEN COMPROMISED BY THE SHORTING OF THE PIM AND THE SOLENOID CONTROL BOARD. THE FAT DEPT. CANNOT INVESTIGATE THIS COMPLAINT ANY FURTHER BECAUSE OF THE SHORTING OF COMPONENTS AND THE RISK IT COULD CAUSE TO THE TEST FIXTURE AND FAT DEPT. TECHNICIAN. THE PROBABLE CAUSE OF THE FAILURE IS PART NUMBER 0997-00-1178 PNEUMATIC MODULE ASSEMBLY SERIAL NUMBER (B)(6), WHERE THE PINCHED WIRE WAS PROBABLE CAUSE OF THE SHORTING OF THE BOARDS. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "IMPOSSIBLE TO DEFINE". SENDING THE 0670-00-1162 PCB, POWER MANAGEMENT, ROHS TO THE SUPPLIER ALONG WITH 0670-00-1161 PCB, SOLENOID CONTROL. RETAINING THE PNEUMATIC MODULE ASSEMBLY IN THE FAT DEPT. PER PROCEDURE NUMBER (B)(4). THE FOLLOWING WAS SUBMITTED BY ANGEL RODRIGUEZ, TECHNICIAN OF THE MAQUET FAILURE ANALYSIS AND TESTING DEPT. (FAT) WAYNE, NJ: AR 5 NOV 2024. FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN 0670-00-1161. PLEASE SEE ATTACHMENT. THEY STATED: 1. PERFORM INCOMING VISUAL INSPECTION RESULT: FOUND COMPONENT AT LOCATION Q7 WAS BURNED. PROBABLE ROOT CAUSE FOR THIS PART IS IMPOSSIBLE TO DEFINE AS THERE WAS NO ACTUAL FAILURE ANALYSIS DONE.. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER 0002-07-D008 REV. AR. THE NON-CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "IMPOSSIBLE TO DEFINE". FAILURE ANALYSIS RECEIVED FROM THE SUPPLIER FOR PN 0670-00-1162. THEY STATED: PERFORM VISUAL CHECK RESULT: NO ABNORMALITY FOUND 2. BOARD WAS RE-TESTED AT FCT RESULT: FAILED STEP 4.7.1.2.B BULK_SR_GOOD UNDER VOLTAGE CIRCUIT (TP68) 3. PERFORM TROUBLESHOOTING ON THE BOARD- FOUND Q31,Q33,Q35 DEFECTIVE. PROBABLE ROOT CAUSE FOR THIS PART IS A MANUFACTURING ASSEMBLY ISSUE. RETAINING THE PART IN THE FAILURE ANALYSIS AND TESTING DEPARTMENT PER PROCEDURE NUMBER (B)(4). THE NON CONFORMANCES WITH THE RETURNED COMPONENTS WERE IDENTIFIED. HOWEVER, THE ROOT CAUSE OR THE MOST PROBABLE ROOT CAUSE IS "MANUFACTURING ASSEMBLY ISSUE".

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING PREVENTIVE MAINTENANCE BY GETINGE FIELD SERVICE ENGINEER, THE CARDIOSAVE INTRA AORTIC BALLOON PUMP (IABP) POWER MANAGEMENT BOARD FAILED. THERE WAS NO PATIENT INVOLVEMENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    478196 CARDIOSAVE HYBRID TYPE "B" PLUG SYSTEM, BALLOON, INTRA-AORTIC AND CONTROL DSP DATASCOPE CORP. - MAHWAH 0998-00-0800-53 10607567108391

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown