BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    AUTOMATED IMPELLA CONTROLLER

    MDR report key: 21906310 · Received April 25, 2025

    Report

    Report Number
    1220648-2025-27830
    Event Type
    Malfunction
    Date Received
    April 25, 2025
    Date of Event
    February 24, 2025
    Report Date
    October 21, 2025
    Manufacturer
    ABIOMED, INC.
    Product Code
    OZD
    PMA / PMN Number
    P140003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE IMPELLA DEVICE HAS BEEN RECEIVED BUT HAS NOT YET BEEN EVALUATED. WHEN THE DEVICE INVESTIGATION HAS BEEN COMPLETED OR ANY NEW INFORMATION HAS BEEN RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED. THIS REPORT IS FOR THE SAME PATIENT AS IN MDR MFR REPORT #: 1220648-2025-27793.

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING FILED AS PART OF A RETROSPECTIVE REVIEW OF HISTORICAL RECORDS. DATA ANALYSIS (IC9542): NOT APPLICABLE BECAUSE THE IC9542 WAS NOT USED WITH THE PUMP (SN: (B)(6) AND IS NOT ASSOCIATED WITH THE REPORTED FM. DATA ANALYSIS (IC7888): ON THE COMPLAINT DATE, FEBRUARY 24, 2025, THE CASE ASSOCIATED WITH THE REPORTED COMPLAINT WAS INITIATED WITH PUMP SN: (B)(6). TWO MINUTES AFTER THE PUMP WAS STARTED, THE CONSOLE DISPLAYED ¿PLACEMENT SIGNAL NOT RELIABLE (OPTICAL SIGNAL-TO-NOISE RATIO) ¿ ALARM,¿ EVENT #130, WHICH WAS AUTOMATICALLY RESOLVED IN 47 MINUTES. THE RT LOG SHOWS THAT THE SNR WAS BELOW 2000 THROUGHOUT THE LOGS, AND THE PS SPIKED TO 3000 (7_RT_LOG_1ST_PSNR.PNG). AFTER 48 MINUTES, THE LOG RECORDED ¿PMD OK STATEREC1937 0 2000 257 0 0 0 0X593 0X593 CPLD 3,¿ INDICATING A PMD RESET CAUSED BY A WATCHDOG TRIGGER. IMMEDIATELY FOLLOWING THE RESET, THE CONSOLE DISPLAYED THE FIRST ¿IMPELLA STOPPED (MECHANICAL/ELECTRICAL ISSUE) ¿ ALARM,¿ EVENT #115. THE RT LOG CONFIRMS THAT THE MOTOR CURRENT DROPPED TO ZERO (10_RT_LOG_1ST_PUMP_STOP_Z.PNG). SUPPORT WAS PROVIDED FOR AN ADDITIONAL 2 HOURS AND 36 MINUTES. DURING THIS PERIOD, MULTIPLE 'IMPELLA STOPPED' EVENTS OCCURRED DUE TO PMD RESETS (IMC_LOGS_IC7888.PDF). THIS FURTHER CONFIRMS THE REPORTED FAILURE MODE. THE LT LOG SHOWS SEVERAL INSTANCES WHERE THE MOTOR CURRENT AND MEAN FLOW DROPPED TO ZERO (1_LT_LOG.PNG). EVERY TIME, THE USER MANUALLY RESTARTED THE PUMP IN THE PREVIOUS P-LEVEL. NOTE: IMC/RT LOG ENTRIES SHOW NO SIGNS OF HIGH MOTOR CURRENT OR CURRENT PHASE MISMATCH. DEVICE ANALYSIS (IC7888): THIS CONSOLE WAS TESTED AFTER ARRIVING AT FS. WHILE RUNNING THE TEST PUMP AT P9, MEASURED 20V AT THE IMPELLATRONIC CONNECTOR (J001.2) AS INTENDED. THIS CONFIRMS THAT THERE IS NO PBM MALFUNCTION. UPON RUNNING THE OPTICAL TEST PUMP FOR 16 HOURS AT P-LEVEL P9, NO PUMP STOPS OCCURRED, CONFIRMING NO IMPELLATRONIC BOARD MALFUNCTION. THE ANALOG OUTPUT FROM THE OPTICAL BENCH SHOWS NO ISSUES AND MATCHES THE KNOWN GOOD OPTICAL BENCH ANALOG OUTPUT. THE OPTICAL PARAMETERS ARE WITHIN SPECIFICATIONS ACCORDING TO THE PM PROCEDURE (0042-7309). THE FRONT PANEL OPTICAL CONNECTOR HAS MINOR DEBRIS, WHICH IS NOT RELATED TO THE REPORTED FAILURE MODE. DURING TESTING, THE CONSOLE DISPLAYED A ¿PURGE PISTON BLOCKED¿ ALARM. UPON VISUAL INSPECTION, MINOR DEBRIS WAS CONFIRMED ON THE PURGE MOTOR GASKET (PURGE_MOTOR_GASKET_IC7888.PNG). THIS IS UNRELATED TO THE REPORTED FAILURE MODE. CORRECTIVE ACTION: FAILURES OF THIS TYPE WILL BE MONITORED FOR TRENDS. PIA-0000551 WAS OPENED IN RESPONSE TO THE POTENTIAL PFA INTERACTION WITH IMPELLA. ROOT CAUSE (IC7888): THE ROOT CAUSE OF THE PUMP STOP WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE THE PMD RESET, OR PUMP STOP. IT IS MOST LIKELY RELATED TO ITS POTENTIAL INTERACTION WITH THE PFA CATHETER, WHICH COULD HAVE INDUCED A PMD RESET AND CAUSED THE LOSS OF MOTOR CURRENT OR SPEED. NO PUMP STOPS OR PMD RESETS WERE OBSERVED ON IC7888 AFTER RUNNING THE OPTICAL TEST PUMP AND CASSETTE FOR 16 HOURS AT P-LEVEL P9 IN THE ENGINEERING LAB. THE ROOT CAUSE FOR THE PSNR WAS NOT DETERMINED DUE TO THE INABILITY TO REPRODUCE IT. AD HOC TASK (IC7888): BEFORE RETURNING THIS CONSOLE BACK TO THE CUSTOMER, FS WAS INSTRUCTED TO PERFORM THE FOLLOWING, CLEAN THE FRONT PANEL OPTICAL CONNECTOR. IF UNABLE TO REMOVE THE DEBRIS, REPLACE THE FRONT PANEL OPTICAL CONNECTOR (0042-2750). CLEAN THE DEBRIS BEHIND THE PURGE CASSETTE HOLDER AND ON THE PURGE MOTOR GASKET. PERFORM SECTIONS 10, 11, 12, 13, 14, 15, 16 AND 23 OF THE PM PROCEDURE (0042-7309) PERFORM A FULL FUNCTIONAL CHECK (0042-7316).

    Additional Manufacturer Narrative · 0

    NOT APPLICABLE BECAUSE CONSOLE 9542 WAS NOT USED WITH THE PUMP (SN: (B)(6)) AND IS NOT ASSOCIATED WITH THE REPORTED FAILURE MODE. THE CORRECT CONSOLE 7888 ASSOCIATED WITH MANUFACTURE DEVICE REPORT 1220648-2025-27830 THE ROOT CAUSE OF THE REPORTED PUMP STOP WAS NOT DETERMINED AS CONSOLE 7888 OR DATA LOGS WERE RETURNED FOR THE INVESTIGATION. B3 DATE OF EVENT WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27830. D4 SERIAL NUMBER, LOT NUMBER, AND UDI NUMBER WERE ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27830. D9 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27830. AS THE CORRECT CONSOLE WAS NOT RECEIVED FOR INVESTIGATION H6 TYPE OF INVESTIGATION CODE 10 WAS ERRONEOUSLY ENTERED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27830. H10 NARRATIVE STATEMENT ERRONEOUSLY STATED THE DEVICE WAS RECEIVED ON THE INITIAL MANUFACTURER DEVICE REPORT NUMBER 1220648-2025-27830.

    Description of Event or Problem · 0

    THE USER FACILITY REPORTED THE 77-YEAR-OLD MALE PATIENT WAS ON IMPELLA CP SUPPORT AND DURING SUPPORT, THE CATHETERS CROSSED IN THE LEFT VENTRICLE AND WHEN THE FIELD MEDICAL CATHETER WAS ABLATING, THE IMPELLA WOULD DROP TO P0 AND THEN THE IMPELLA WAS MANUALLY BROUGHT UP TO THE PREVIOUS P LEVEL. THIS OCCURRED SEVERAL TIMES THROUGHOUT THE CASE. THE AIC TEAM REQUESTED THAT THE AIC BE INVESTIGATED FOR THE ISSUE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1275606 AUTOMATED IMPELLA CONTROLLER TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. AUTOMATED IMPELLA CONTROLLER 1464780

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male