BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24480265 · Received March 2, 2026

    Report

    Report Number
    1220648-2026-04294
    Event Type
    Injury
    Date Received
    March 2, 2026
    Date of Event
    October 29, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ABIOMED INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ABIOMED INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 0

    68 YEAR OLD MALE PATIENT SUPPORTED WITH IMPELLA CP DUE TO CHEST PAIN AND CHANGES IN ECG. THE PATIENT WAS EMERGENTLY TAKEN TO THE CATHETER LABORATORY AND MULTIVESSEL CORONARY ARTERY DISEASE WAS DIAGNOSED.DECISION WAS TAKEN TO INSERT AN IMPELLA CP FOR HEMODYNAMIC SUPPORT AND PERFORM A BALOON ANGIOPLASTY. HCPS WERE MADE AWARE OF RECOMMENDATIONS REGARDING THE IMPELLA 14 X 13 SHEATH REMAINING IN THE LEFT COMMON FEMORAL, WHICH IS AGAINST THE RECOMMNDATIONS IN THE INSTRUCTIONS FOR USE. WILL CONTINUE TO MONITOR AND FOLLOW CLOSELY. DAY OF PROCEDURE IMPELLA CP SHOWED ¿POSITION IN AORTA¿ ALARM ON AUTOMATED IMPELLA CONTROLLER DESPITE FLUROSCOPY CONFIRMING LEFT VENTRICLE PLACEMENT. RECOMMENDATION WAS MADE TO SWITCH OUT IMPELLA CP. ADMINISTRATION OF HOSPITAL REQUESTED THE AUTOMATED IMPELLA CONTROLLER TO BE EXCHANGE DUE TO A RECALL JUNE 23/2025 AND POSSIBLE ISSUES RELATED TO THIS. DAY ONE OF SUPPORT, PATIENT DEVELOPED NEW ECG CHANGES AND BECAME INCREASINGLY DIAPHORETIC - CONSERVATIVELY CODED TO ARRHYTHMIA AND TEMRORARY IMPAIRMENT. INCREASED USE OF VASOACTIVE MEDICATIONS WERE REQUIRED. AFTER ONE DAY OF SUPPORT, CONCERNS WITH PATIENT HAVING DECREASED LEFT DISTAL PULSES, SO THE DECISION WAS MADE TO EXPLANT THE DEVICE - CONSERVATIVELY CODED TO HYPERTENSION AND MEDICAL DEVICE REMOVAL. PALPABLE PULSES WERE NOTED WITH NO FURTHER CONCERNS OR ISSUES. PATIENT SUCCESSFULLY WEANED AFTER ONE DAY OF SUPPORT. DURING THE IMPELLA CP IMPLANT PROCEDURE ON (B)(6) 2025, THERE WAS A PLACEMENT SIGNAL ISSUE. DESPITE FLUOROSCOPY CONFIRMING CORRECT PLACEMENT IN THE LEFT VENTRICLE, THERE WAS AN ACTIVE ""IMPELLA POSITION IN AORTA"" ALARM ON THE AUTOMATED IMPELLA CONTROLLER (AIC) . HOSPITAL STAFF FOLLOWED THE RECOMMENDATION TO EXCHANGE THE PUMP FOR A NEW IMPELLA CP. THE ISSUE WAS RESOLVED WITH SUPPORT PROVIDED FROM A NEW IMPELLA CP AND DIFFERENT AIC. HOSPITAL ADMINISTRATION NOTICED THAT THE AIC USED WHEN THE PLACEMENT SIGNAL ISSUE OCCURRED FELL UNDER AN AIC RECALL FROM JUNE 23, 2025. IT IS UNCLEAR WHETHER THE ISSUE WAS RELATED TO AN OPTICAL SENSOR ISSUE OR AN AIC ISSUE, SO IT WAS CODED AGAINST BOTH."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    33218 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026710899 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Male Required Intervention