BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PUMP 381 PUMP SET (US)

    MDR report key: 24136094 · Received January 21, 2026

    Report

    Report Number
    1220648-2026-01266
    Event Type
    Injury
    Date Received
    January 21, 2026
    Date of Event
    December 22, 2025
    Manufacturer
    ABIOMED, INC. - 1220648
    Product Code
    OZD
    UDI-DI
    00813502011876
    PMA / PMN Number
    P140003
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTION: SECTION E : THE FACILITY INFORMATION WAS INADVERTENTLY LEFT OUT IN THE INITIAL REPORT WHICH HAS BEEN ADDED TO THIS REPORT. INVESTIGATION SUMMARY: NO PRODUCT RETURN: ISCHAEMIA: IN ORDER TO MAKE A CAUSE DETERMINATION, ALL OF THE CLINICAL DETAILS OUTLINED IN ES2023-0158 WOULD HAVE TO BE PROVIDED. THE ROOT CAUSE OF THE INJURY WAS UNABLE TO BE DETERMINED DUE TO INSUFFICIENT CLINICAL DETAILS. ASAE/MAJOR BLEED: BLEEDING NOTED AT LEFT GROIN IMPELLA SITE. SUTURE PLACED TO RESOLVED BLEEDING. THE CAUSE OF THE ACCESS SITE ADVERSE EVENT WAS USER RELATED AS BLEEDING RESOLVED BY ADDING A SUTURE. DEVICE HISTORY REVIEW: THE PUMP SN (B)(6) PASSED ALL THE POST STERILE INSPECTION CHECKS.

    Additional Manufacturer Narrative · 0

    ADDITIONAL INFORMATION WAS PROVIDED IN B2 (IS REQUIRED INTERVENTION). UPON REVIEW, IT WAS IDENTIFIED THAT IT WAS INADVERTENTLY OMITTED IN ERROR IN THE INITIAL REPORT. ADDITIONAL INFORMATION HAS BEEN PROVIDED IN B5 (EVENT DESCRIPTION). CORRECTED INFORMATION HAS BEEN PROVIDED IN H4 (DEVICE MANUFACTURE DATE). 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.

    Additional Manufacturer Narrative · 0

    A4: PATIENT WEIGHT IS UNKNOWN. THE IMPELLA DEVICE WAS NOT RECEIVED FROM THE CUSTOMER; THEREFORE, INVESTIGATION OF THE DEVICE WAS NOT POSSIBLE. SHOULD THE DEVICE OR ANY NEW INFORMATION BE RECEIVED, A SUPPLEMENTAL MDR WILL BE FILED.

    Description of Event or Problem · 0

    ADDITIONAL INFORMATION INDICATES THAT NO FURTHER INTERVENTIONS WERE PERFORMED OTHER THAN CONTINUED TISSUE OXIMETRY MONITORING AND VASOPRESSOR WEANING AS TOLERATED. THE PATIENT WAS TRANSFERRED TO (B)(6) ON (B)(6) 2025, AND NO ADDITIONAL INFORMATION IS AVAILABLE AFTER THAT TIME.

    Description of Event or Problem · 0

    A 34-YEAR-OLD FEMALE WITH NON-ISCHEMIC DECOMPENSATED CARDIOMYOPATHY REQUIRED MECHANICAL CIRCULATORY SUPPORT. ON ARRIVAL TO THE INTENSIVE CARE UNIT (ICU), THE STAFF WAS UNABLE TO OBTAIN PULSE WITH DOPPLER IN THE BILATERAL LOWER EXTREMITIES. THE PHYSICIAN STATED THAT VESSELS WERE SMALL BUT ALSO CLAMPED DOWN DUE TO HIGH DOSES OF PRESSORS (NOREPINEPHRINE WAS AT 60 MCG/MIN, WHICH HAS SINCE BEEN WEANED TO 40, AND VASOPRESSIN AT 0.03 UNITS/MIN). VENO-ARTERIAL EXTRACORPOREAL MEMBRANE OXYGENATION (VA-ECMO) ARTERIAL CANNULATION IS IN RADIOFREQUENCY ABLATION (RFA) AND IMPELLA IS IN THE LEFT FEMORAL ARTERY (LFA). DISTAL PERFUSION CATHETER PLACED FOR RIGHT LEG, BUT THE PHYSICIAN BELIEVES ONCE DRIPS ARE WEANED DOWN, THE LEFT LEG WILL NOT REQUIRE DISTAL PERFUSION CATHETER BUT CONTINUED TO MONITOR WOULD READDRESS IF NOT IMPROVING. BOTH EXTREMITIES WERE COOL TO TOUCH BUT EQUAL AND THE COLOR NOT ABNORMAL. ADDITIONALLY, THE NURSE REPORTED THAT THE LEFT GROIN IMPELLA SITE WAS BLEEDING EARLIER THIS MORNING. SUTURE PLACED AT BEDSIDE AND BLEEDING RESOLVED. PARTIAL THROMBOPLASTIN TIME (PTT) >200 (PT HAD RECEIVED 12000 UNITS OF HEPARIN IN CATH LAB BUT SYSTEMIC DRIP NOT STARTED YET). ARGATROBAN DRIP ORDERED PER HOSPITAL PROTOCOL BUT HAS NOT BEEN STARTED. 2 UNITS PRBCS TRANSFUSED. DRESSING CHANGED BY NURSE PRIOR TO LOCAL TEAM ROUNDS AND HAS NO FURTHER BLEEDING OR HEMATOMA. DRESSING WAS APPROPRIATELY ANGLE MATCHED AND WAS DRY AND INTACT AND SECURED. PATIENT WAS SEDATED AND NOT MOVING EXTREMITIES. THE PLAN IS TO CONTINUE TO MONITOR FOR BLEEDING AND PTT WILL START SYSTEMIC ANTICOAGULATION WHEN APPROPRIATE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    442733 PUMP 381 PUMP SET (US) TEMPORARY NON-ROLLER TYPE LEFT HEART SUPPORT BLOOD PUMP OZD ABIOMED, INC. - 1220648 2026776437 00813502011876

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Female Other| R