BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CENTRIMAG BLOOD PUMP

    MDR report key: 21337708 · Received February 7, 2025

    Report

    Report Number
    3003306248-2025-00042
    Event Type
    Injury
    Date Received
    February 7, 2025
    Date of Event
    October 19, 2024
    Report Date
    April 30, 2025
    Manufacturer
    THORATEC SWITZERLAND GMBH
    Product Code
    DSQ
    UDI-DI
    0007640135140627
    PMA / PMN Number
    K020271
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    B5: SPECIFIC PATIENT INFORMATION AND DEVICE SERIAL NUMBER ARE DOCUMENTED AS UNKNOWN; DETAILS ARE LISTED IN THE ATTACHED ARTICLE. DEVICE WAS IMPLANTED AT TIME OF EVENT. DATE OF EVENT HAS BEEN ENTERED AS THE DATE OF PUBLICATION 19OCT2024 SINCE THE DATE OF DATA COLLECTION WAS NOT PROVIDED. AUTHOR INFORMATION: VILA-GARCÍA, J., MARCO CLEMENT, I., POVEDA PINEDO, I. D., LOECHES YAGÜE, B., CID MENÉNDEZ, A., & MORENO, R. (2024). FIRST EVIDENCE OF A HEARTMATE 3 DRIVELINE INFECTION BY RHIZOPUS ARRHIZUS: A CASE REPORT. THE CANADIAN JOURNAL OF CARDIOLOGY, 40(12), 2637¿2639. HTTPS://DOI.ORG/10.1016/J.CJCA.2024.10.013. LA PAZ UNIVERSITY HOSPITAL, HOSPITAL LA PAZ INSTITUTE FOR HEALTH RESEARCH- IDIPAZ, MADRID, SPAIN. THE REPORTABLE AWARE DATE IS THE DATE THE SJM NOTIFIER COMPLETED READING THE ARTICLE AND ENTERED IN THE COMPLAINT DATABASE (PER SECTION 6.3.4 OF 90979616). H6: ADDITIONAL HEALTH EFFECT- CLINICAL CODES: ULCER-E2339, HEMODYNAMIC INSTABILITY-E2343 NO FURTHER INFORMATION PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED ONCE THE MANUFACTURER INVESTIGATION IS COMPLETE.

    Additional Manufacturer Narrative · 0

    THIS EVENT WAS DETERMINED TO BE SUPPLEMENTAL INFORMATION. THE INVESTIGATION FINDINGS WILL BE SUBMITTED UNDER MFR #: 3003306248-2025-00151.

    Description of Event or Problem · 0

    IT WAS REPORTED THROUGH THE RESEARCH ARTICLE ¿FIRST EVIDENCE OF A HEARTMATE 3 DRIVELINE INFECTION BY RHIZOPUS ARRHIZUS: A CASE REPORT¿ THAT HEARTMATE 3 (HM3) MAY BE ASSOCIATED WITH INFECTION AND DEATH. THE PATIENT HAD A HISTORY OF ISCHEMIC CARDIOMYOPATHY AND HAD AN IMPLANTED CARDIAC DEFIBRILLATOR. THE PATIENT HAD MULTIPLE IMMUNOSUPPRESSIVE RISK FACTORS INCLUDING TYPE 2 DIABETES, CHRONIC KIDNEY DISEASE, AND ADVANCED HEART FAILURE. THE PATIENT DEVELOPED UROSEPTIC SHOCK BEFORE THE HM3 IMPLANTATION AND WAS THUS TREATED WITH MEROPENEM FOR A PERIOD OF 10 DAYS. AFTER THE INFECTION WAS TREATED THE HM3 LEFT VENTRICULAR ASSIST DEVICE (LVAD) WAS IMPLANTED. DUE TO INTRAOPERATIVE RIGHT VENTRICULAR (RV) FAILURE, A RV CENTRIMAG WAS IMPLANTED. ANTIBIOTIC PROPHYLAXIS WITH DAPTOMYCIN AND CEFTAZIDIME-AVIBACTAM WAS THEN PRESCRIBED DUE FOR A OXACILLINASE-48 (OXA-48) BACTERIAL INFECTION. FOR 2 DAYS AFTER SURGERY BLEEDING THROUGH CHEST TUBES PERSISTED. 2 ADDITIONAL SURGICAL INTERVENTIONS WERE REQUIRED TO CONTAIN BLEEDING. LAB TESTS REVEALED PROGRESSIVE INCREASE IN LEUKOCYTE COUNT AND C-REACTIVE PROTEIN (203.0MG/DL), IN ADDITION TO ELEVATED PROCALCITONIN LEVELS(1.08NG/DL). TO ADDRESS THE INFECTION, ANIDULAFUNGIN, DAPTOMYCIN AND CEFTAZIDIME-AVIBACTAM WERE PRESCRIBED. 10 DAYS POST IMPLANT ANTIMICROBIAL DRUGS WERE STOPPED BECAUSE OF CLINICAL IMPROVEMENT. 23 DAYS AFTER HM3 IMPLANTATION PURULENT DRAINAGE WAS OBSERVED IN STERNOTOMY WOUND. THIS WAS TREATED WITH TEICOPLANIN, CEFTAZIDIME-AVIBACTAM AND ANIDULAFUNGIN. LATER THE SAME PURULENT DRAINAGE WAS DETECTED AT THE HM3 DRIVELINE INSERTION SITE AND A SKIN ULCER APPEARED ABOVE THE DRIVELINE PATHWAY. CULTURES FROM THESE SITES IDENTIFIED R ARRHIZUS. THIS LED TO ANIDULAFUNGIN TO BE REPLACED WITH INTRAVENOUS AMPHOTERICIN B AND ORAL POSACONAZOLE. A SOFT TISSUE ULTRASOUND SHOWED PHLEGMONOUS CHANGES AROUND THE DRIVELINE WITHOUT A CLEAR ABSCESS. R ARRHIZUS WAS NOT FOUND IN BLOOD, URINE, OR BRONCHIAL ASPIRATE CULTURES. A TRANSESOPHAGEAL ECHOCARDIOGRAM WAS PERFORMED REVEALING VEGETATION CONSISTENT WITH IMPLANTABLE CARDIAC DEFIBRILLATOR-RELATED ENDOCARDITIS. PATIENT PASSED AWAY DUE TO SEPTIC SHOCK 33 DAYS AFTER HM3 IMPLANTATION. THE ARTICLE CONCLUDED THAT EARLY RECOGNITION AND TREATMENT OF FUNGAL INFECTIONS IN LVAD PATIENTS IS ESSENTIAL AND PROMPT INVESTIGATION OF NONSPECIFIC SYMPTOMS THAT COULD POINT TO INFECTION IS ESSENTIAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    107549 CENTRIMAG BLOOD PUMP VENTRICULAR (ASSIST) BYPASS DSQ THORATEC SWITZERLAND GMBH 102953 0007640135140627

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention| H| L