BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60

    MDR report key: 2348978 · Received November 16, 2011

    Report

    Report Number
    1225520-2011-00002
    Event Type
    Injury
    Date Received
    November 16, 2011
    Date of Event
    January 26, 2011
    Report Date
    October 26, 2011
    Manufacturer
    HARVEST TECHNOLOGIES CORPORATION
    Product Code
    JQC
    PMA / PMN Number
    BK000037
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    DENTIST

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT DID NOT REPORT ANY SYMPTOMS OF AN ILLNESS PRIOR TO THE PROCEDURE. A SPECIMEN WAS SENT BY THE DENTIST TO IDENTIFY THE MICROORGANISM RESPONSIBLE FOR THE INFECTION. SPECIMEN REPORT WAS HEAVY GROWTH OF (B)(6). THE PATIENT WAS PLACED ON PROPHYLACTIC ANTIBIOTICS THE DAY BEFORE SURGERY AND CONTINUED TO TAKE THEM DURING THE COURSE OF THE INFECTION. ANTIBIOTICS WERE CHANGED DURING THE COURSE OF THE INFECTION. ANTIBIOTIC THERAPY INCLUDED; AMOXICILLIN DAY PRIOR TO SURGERY, (B)(6) 2011 AUGMENTIN/FLAGYL, (B)(6) 2011 FLAGYL/LEVAQUIN, AND (B)(6) 2011 EXTENDED FLAGYL COURSE. THERE WAS NO EVIDENCE AND CONTINUES TO BE NO EVIDENCE OF INFECTION ASSOCIATED WITH A ROOT CANAL OR ANY ABSCESS. THE SINUS MEMBRANE WAS INTACT AND NOT COMPROMISED. THE GRAFT MATERIAL WAS TAKEN OUT. PATIENT HAD UNREMARKABLE MEDICAL HISTORY. PATIENT IS DOING WELL TODAY, BUT HAS DECLINED ANOTHER SINUS AUGMENTATION PROCEDURE AND WILL NOT BE GETTING AN IMPLANT. INFECTION HAS RESOLVED. HOSPITALIZATION WAS NOT NECESSARY. THERE WAS NO PERMANENT INJURY OR DISABILITY. WE ALSO CONSULTED DR. (B)(6), ORAL SURGEON, IN HIS OPINION, THERE ARE MANY POTENTIAL CAUSES FOR AN INFECTION IN A SURGICAL PATIENT. HE DOES NOT UNDERSTAND HOW THE PRACTITIONER CAN CONCLUDE THE APC60 PACK WAS THE SOURCE. HE EXPLAINED (B)(6) IS A COMMON CONTAMINANT ON SKIN, IN NASAL PASSAGES, AND ON INSTRUMENTS NO PROPERLY DISINFECTED. HE QUESTIONED THE PRACTITIONER'S INFECTION CONTROL PROCESSES FOR SURGICAL INSTRUMENT, AND THE SURGICAL AND ASEPTIC TECHNIQUES UTILIZED. WE HAVE INVESTIGATED THIS REPORT BY REVIEWING THE PRODUCT LOT HISTORY RECORDS, WHICH WE FOUND IN ORDER. THE STERILIZATION RECORDS WERE ACCEPTABLE. THERE WERE NO DEVIATIONS. WE HAVE NOT RECEIVED A SIMILAR REPORT FROM ANY CUSTOMER.

    Description of Event or Problem · 1

    (B)(6), REPORTED THAT PATIENT HAD A SINUS AUGMENTATION PROCEDURE DUE TO INADEQUATE VERTICAL HEIGHT FOR FUTURE DENTAL IMPLANT PROCEDURE AND DEVELOPED AN INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HARVEST SMARTPREP2 CENTRIFUGE SYSTEM, APC60 PLATELET CONCENTRATION SYSTEM JQC HARVEST TECHNOLOGIES CORPORATION APC60 APC60-0101

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention LOCAL ANESTHETIC 2 PERCENT XYLOCAINE WITH 1:100| STARTED ANTIBIOTICS ON (B)(6) 2011, RECEIVED THE| PRESSURE, HEART RATE, RESPIRATORY RATE, AND OXYGEN| EPINEPHRINE AS WELL AS .5 PERCENT MARCAINE WITH| DEMEROL, TORADOL, AND ZOFRAN, GIVEN INTRAVENOUSLY.| FOLLOWING MEDICATIONS DURING PROCEDURE. VERSED,| ALSO, RECEIVED OXYGEN/NITROUS OXIDE VIA NASAL| (B)(6) 2011, AND| SMELL, CHILLS, AND FEVER. OTHER MATERIALS USED| DURING THE PROCEDURE, ACE SURGICAL SUPPLY,| 06/2013 AND LOT #BMCU09N2 EXP: 11/2012. THIS| NOTED, WITH SWELLING, DISCOMFORT, BAD TASTE AND| CANNULA. PATIENT WAS SEEN ON (B)(6),| (B)(6)2011. ON VISIT (B)(6)2011 ACTIVE SUPPURATION| PRODUCT IS STERILIZED BY GAMMA-IRRADIATIN AND| NUOSS CANCELLOUS BONE 2 GRAMS/.25-1MM PARTICLE| SIZE REF(B)(4), LOT NUMBERS BMCU10F4, EXP:| WAS OPENED JUST PRIOR TO PLACEMENT. A GUIDOR| MEMBRANE WAS ALSO USED (B)(4), LOT#P6 008-090025| SATURATION BEFORE, DURING AND AFTER PROCEDURE.| 1:200 EPINEPHRINE. PATIENT MONITORED, BLOOD| EXP. 04/01/2011.