BEUDAMED
    FDA Adverse Event Death Summary report: N

    STIMULAN RAPID CURE

    MDR report key: 7369050 · Received March 26, 2018

    Report

    Report Number
    9617083-2018-00001
    Event Type
    Death
    Date Received
    March 26, 2018
    Date of Event
    February 5, 2018
    Report Date
    March 6, 2018
    Manufacturer
    BIOCOMPOSITES LTD
    Product Code
    MQV
    UDI-DI
    50601557110270
    PMA / PMN Number
    K141830
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    THE ISSUE WAS FIRST IDENTIFIED 48 HOURS POST OP, IT WASN'T ANTICIPATED BUT REPORTED THAT IN RETROSPECT AFTER REVIEWING OR NOTES AND FINDING THE AMOUNT OF TOBRAMYCIN USED, IT COULD HAVE BEEN ANTICIPATED. INITIALLY TO RESOLVE THE ISSUE A FEMORAL DIALYSIS CATHETER WAS PLACED AND THE PATIENT WAS TRANSFERRED TO A HIGHER LEVEL OF CARE (FACILITY WITH NEPHROLOGY SERVICE). SURGEON STATED THAT THE AKI COULD BE RELATED TO SURGERY OR SEPSIS. THERE IS NO SUGGESTION THAT STIMULAN RAPID CURE CAUSED OR CONTRIBUTED TO THE PATIENTS RENAL FAILURE - THE SURGEON WAS TRYING TO PROLONG LIFE. THE TREATING PHYSICIAN HAS NO CONCERNS REGARDING THE DEVICE. VANCOMYCIN AND TOBRAMYCIN ARE CLINICALLY BOTH KNOWN TO BE NEPHROTOXIC AND DUE TO THE LARGE QUANTITIES USED MAY HAVE CONTRIBUTED TO THE PATIENT'S CONDITION.

    Description of Event or Problem · 1

    REPORT BEING SUBMITTED TO MATCH CUSTOMERS REPORT. 20 FEB 2018 IT WAS REPORTED BY THE HOSPITAL PHARMACIST THAT A PATIENT PRESENTED WITH RENAL FAILURE 48 HOURS, POST SURGERY. SURGERY - PJI, EXPLANTATION SEPTIC LEFT KNEE. THE FOLLOWING ANTIMICROBIALS WERE GIVEN POST AND PRE SURGERY: PRE-OP: 2GM CEFAZOLIN IVPB, 1500MG VANCOMYCIN IVPB BACITRACIN IRRIGATION, 2.4GM TOBRAMYCIN & 8MG VANCOMYCIN MIXED IN 80GM PMMA 2GM VANCOMYCIN MIXED WITH 5CC, STIMULAN RAPID CURE TO MAKE BEADS; 1GM VANCOMYCIN IN WOUND BED; POST-OP: 2GM NAFCILLIN IVPB. ON 29 FEB 2018 INFORMATION RECEIVED REGARDING THE DEATH OF THE PATIENT, 15 DAYS POST EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    214464 STIMULAN RAPID CURE BONE VOID FILLER MQV BIOCOMPOSITES LTD 620-005 10/17-R354 50601557110270

    Patients

    Seq Age Sex Outcome Treatment
    1 Death| R BACITRACIN| CEFAZOLIN| NAFCILLIN| TOBRAMYCIN| VANCOMYCIN