BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HAVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60

    MDR report key: 2593074 · Received May 24, 2012

    Report

    Report Number
    1225520-2012-00002
    Event Type
    Injury
    Date Received
    May 24, 2012
    Date of Event
    April 10, 2012
    Report Date
    May 24, 2012
    Manufacturer
    HARVEST TECHNOLOGIES CORPORATION
    Product Code
    JQC
    PMA / PMN Number
    K103340
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MY
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE DEVICE HISTORY RECORD FOR THE LOT WAS REVIEWED AND NO DEVIATIONS WERE NOTED. TWO ADVERSE EVENTS WERE REPORTED BY THE SAME SURGEON FOR THIS LOT OF PRODUCT. THE OTHER EVENT HAS BEEN REPORTED UNDER MDR NUMBER 1225520-2012-0001. ASIDE FROM THESE TWO REPORTED EVENTS, THERE HAVE BEEN NO OTHER ADVERSE EVENTS REPORTED AGAINST THIS LOT. IN ADDITION, WE HAVE HAD NO PRIOR REPORTS OF DVT OR PULMONARY EMBOLISM RELATED TO THE PRODUCT. HARVEST TECHNOLOGIES CONSULTED OUR CLINICAL ADVISER AND QUERIED THE SITE TO PROVIDE MORE DETAILS CONCERNING PRE-EXISTING CONDITIONS OF THE PATIENT THAT MAY HAVE CONTRIBUTED TO THIS EVENT. THE INVESTIGATION REVEALED THAT SEVERAL RISK FACTORS FOR A DVT / PE WERE PRESENT. THE PATIENT WAS A SMOKER, A TOURNIQUET WAS USED DURING THE PROCEDURE, AND NO ANTICOAGULANT PROPHYLAXIS WAS ADMINISTERED. OUR MEDICAL ADVISER, (B)(4). PROVIDED THE FOLLOWING REFERENCE INFORMATION: "HOSPITAL FOR SPECIAL SURGERY QUALITY ASSURANCE COMMITTEE FINAL REPORT CONTAINS THE FOLLOWING STATEMENTS: THE PREVALENCE OF DEEP VEIN THROMBOSIS (DVT) FOLLOWING KNEE ARTHROSCOPY IS APPROXIMATELY EIGHT PERCENT. NINETY-NINE PERCENT OF THESE CLOTS ARE DISTAL [10] [11] [12] [13] [14]. CLINICALLY EVIDENT POSTOPERATIVE PULMONARY EMBOLISM (PE) FOLLOWING KNEE ARTHROSCOPY IS RARE, BUT DOES OCCUR. BECAUSE OF THE RELATIVELY LOW RATE OF POSTOPERATIVE VTE, PROPHYLAXIS CANNOT BE MANDATED IN ALL CASES. STUDIES SUGGEST, HOWEVER, THAT THERE ARE SURGICAL AND CLINICAL RISK FACTORS THAT CAN BE USED TO IDENTIFY PATIENTS AT HIGHER THAN AVERAGE RISK FOR POSTOPERATIVE VTE FOLLOWING KNEE ARTHROSCOPY [10] [11] [12] [13] [14].

    Description of Event or Problem · 1

    SITE REPORTED THAT PATIENT WITH LEFT KNEE PAIN FOR 3 MONTHS WAS DIAGNOSED WITH DEGENERATIVE MENISCAL TEAR. THE PATIENT WAS TREATED WITH ARTHROSCOPIC DEBRIDEMENT FOLLOWED BY PRP INJECTION. PATIENT RETURNED WITH CALF PAIN 6 DAYS AFTER THE TREATMENT. AT DAY 12, HE DEVELOPED CHEST PAIN AND SHORTNESS OF BREATH. PATIENT WAS DIAGNOSED WITH PULMONARY EMBOLISM. NEEDED MONITORING AND OXYGEN SUPPLEMENTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HAVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60 PLATELET CONCENTRATE SYSTEM JQC HARVEST TECHNOLOGIES CORPORATION APC60 863502-0023

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Hospitalization| L| R