BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOPATCH, UNKNOWN SIZE/PRODUCT ID

    MDR report key: 16733042 · Received April 13, 2023

    Report

    Report Number
    2648988-2023-00014
    Event Type
    Injury
    Date Received
    April 13, 2023
    Report Date
    May 10, 2023
    Manufacturer
    INTEGRA NEUROSCIENCES PR
    Product Code
    FRO
    PMA / PMN Number
    K003229
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    THE BIOPATCH WAS NOT RETURNED FOR EVALUATION AND LOT NUMBER INFORMATION HAS NOT BEEN PROVIDED; THEREFORE, AN EVALUATION OF THE DEVICE COULD NOT BE PERFORMED, AND MANUFACTURING RECORDS COULD NOT BE REVIEWED. THE CAUSE(S) OF THE DIFFICULTY REPORTED BY THE CUSTOMER COULD NOT BE DETERMINED; HOWEVER, THE MOST PROBABLE ROOT CAUSE IS MOST LIKELY ATTRIBUTABLE TO THE UNDERLYING HEALTH CONDITIONS OF THE PATIENTS WITHIN THE STUDY. IF ADDITIONAL RELEVANT INFORMATION BECOMES AVAILABLE IN THE FUTURE, THIS COMPLAINT WILL BE REOPENED, AND THE RESPECTIVE EVALUATION PERFORMED. TRENDS WILL BE MONITORED FOR THIS AND SIMILAR ISSUES. AT PRESENT, WE CONSIDER THIS COMPLAINT TO BE CLOSED.

    Additional Manufacturer Narrative · 0

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 0

    ASAIO JOURNAL (2022) PUBLISHED: "COLONIZATION WITH MULTIDRUG-RESISTANT ORGANISMS IN PATIENTS WITH VENTRICULAR ASSIST DEVICES". "IN THIS RETROSPECTIVE COHORT, WE CHARACTERIZE THE INCIDENCE, RISK FACTORS, AND CLINICAL OUTCOMES OF VENTRICULAR ASSIST DEVICES PATIENTS WITH MULTIDRUG-RESISTANT ORGANISMS' COLONIZATION OVER A 10-YEAR PERIOD. BETWEEN JULY 2008 AND SEPTEMBER 2018, 378 PATIENTS VENTRICULAR ASSIST DEVICES SUPPORT WERE INCLUDED IN THE STUDY. THERE WERE 293 MALES AND 85 FEMALES WITH A MEAN AGE OF 55.0 (+/-13.5) YEARS. SECOND GENERATION VENTRICULAR ASSIST DEVICES (AXIAL-FLOW) IMPLANTED INCLUDED THE HEARTMATE II (MANUFACTURER:THORATEC CORP). THIRD GENERATION VENTRICULAR ASSIST DEVICES (CENTRIFUGAL FLOW) IMPLANTED INCLUDED THE HEARTMATE 3 (MANUFACTURER: ABBOTT) AND HEARTWARE (MANUFACTURER: MEDTRONIC) AND IN SELECT PATIENTS, THE VENTRASSIST (MANUFACTURER: VENTRACOR LTD). FOLLOWING VENTRICULAR ASSIST DEVICES IMPLANTATION, DRESSING CHANGES WERE PERFORMED 3 TIMES WEEKLY BY CAREGIVERS WITH 2% CHLORHEXIDINE GLUCONATE CLEANSING AND USE OF A COMPETITOR SORBAVIEW SHIELD (MANUFACTURER: CENTURION) OVER THE DRIVELINE EXIT SITE. IF PATIENTS DEVELOPED CONTACT DERMATITIS OR ALLERGIES TO CHLORHEXIDINE GLUCONATE, POVIDONE-IODINE WAS SUBSTITUTED AS THE PRIMARY AGENT FOR CLEANSING. IN A SELECT MINORITY OF PATIENTS, CHANGES TO THE ABOVE STRATEGY INCLUDED A BIOPATCH PROTECTIVE DISK (ETHICON) APPLIED TO THE EXIT SITE, A 72-HOUR DRESSING INSTEAD OF A 24-HOUR DRESSING, AND SELF-DRESSING CHANGES IN LIEU OF CAREGIVER CHANGES." CONCLUSION: MULTIDRUG-RESISTANT ORGANISMS COLONIZATION IS COMMON AFTER VENTRICULAR ASSIST DEVICES IMPLANTATION AND IS ASSOCIATED WITH FUTURE VENTRICULAR ASSIST DEVICES INFECTIONS. FURTHER STUDY IS NEEDED TO DETERMINE BEST MANAGEMENT. ADVERSE EVENT: DRIVELINE INFECTION (N=?) TREATMENT: LONG-TERM SYSTEMIC ANTIBIOTICS AND ENTIRE DEVICE EXCHANGES (REVISION SURGERY). HTTPS://ORCID.ORG/0000-0001-7348-6716.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1456653 BIOPATCH, UNKNOWN SIZE/PRODUCT ID ANTIMICROBIAL PRODUCTS FRO INTEGRA NEUROSCIENCES PR

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown