BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24621556 · Received March 17, 2026

    Report

    Report Number
    1220648-2026-05473
    Event Type
    Injury
    Date Received
    March 17, 2026
    Date of Event
    August 1, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502012279
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION SUBSEQUENTLY RECEIVED CONFIRMED THE ONLY INTERVENTION KNOWN WAS MANUAL PRESSURE. THIS DEVICE WAS UNAVAILABLE FOR RETURN AS INDICATED WITH INITIAL REPORTING. NOTE: SECTION H6 HEALTH EFFECT-CLINICAL, HEALTH EFFECT-IMPACT, MEDICAL DEVICE PROBLEM CODING AND INVESTIGATION TYPE, FINDINGS, AND CONCLUSION CODING REMAIN UNCHANGED FROM THE INITIAL REPORT.

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT #(B)(4). 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. INVESTIGATION SUMMARY ACCESS SITE BLEEDING: THE ROOT CAUSE OF THE ACCESS SITE BLEEDING WAS MOST LIKELY USE RELATED SINCE HEMATOMA NOTED DURING TRANSPORT OF IMPELLA DEVICE FROM DANBURY HOSPITAL TO YNHH. DEVICE HISTORY DEVICE LOT: 1832369 DEVICE HISTORY REVIEW THE PUMP SN: (B)(6) PASSED ALL POST STERILE INSPECTION CHECKS. QN # (B)(4) WAS FOR THE BATCH # 1832369 FOR PPM FAILED FOR SN #(B)(6) WHICH WERE REWORKED. THIS IS UNRELATED TO THIS FAILURE MODE.

    Description of Event or Problem · 0

    65-YEAR-OLD MALE PATIENT WITH CARDIOGENIC SHOCK IMPLANTED WITH IMPELLA CP UNEVENTFULLY. DURING PATIENT TRANSPORT FOR ADVANCED CARE, A HEMATOMA WAS NOTED AT ACCESS SITE. HEMATOMA RESOLVED WITH MANUAL PRESSURE WITH NO PATIENT INJURY. PHYSICIAN DECIDED TO ESCALATE SUPPORT TO ECMO AND REMOVE IMPELLA.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    682366 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2025529131 00813502012279

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Male Required Intervention