BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CE INFUSOR LV 2, 12 PACK

    MDR report key: 1890424 · Received November 3, 2010

    Report

    Report Number
    6000001-2010-04699
    Event Type
    Malfunction
    Date Received
    November 3, 2010
    Date of Event
    October 12, 2010
    Report Date
    October 13, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    PMA / PMN Number
    K041738
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BR
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION. THE REPORTED CONDITION OF "BACKFLOW" WAS CONFIRMED DUE TO A FRAGMENT OF ACRYLIC RESIN (SIZE 1.8 MM) FOUND TRAPPED BETWEEN THE CHECK-BAND AND STRESS-MEMBER. THIS IS A SINGLE USE DEVICE AND WILL NOT BE REPAIRED. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Additional Manufacturer Narrative · 1

    (B)(4). ADDITIONAL NARRATIVE: THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    EARLY RESULTS OF CLINICAL EXPERIENCE WITH A NEW MEDIAL SCREW TRAJECTORY INSERTION TECHNIQUE ARE GIVEN (THE PEDICLE SCREW TRAJECTORY IS ALTERED SO THAT THE SCREW IS DIRECTED THROUGH THE PEDICLE CORTICAL BONE ONLY). THE RETROSPECTIVE REVIEW OF PERI-OPERATIVE AND POST-OPERATIVE COMPLICATIONS INCLUDES CONSECUTIVE PATIENTS, AGE 18 OR OLDER, WHO UNDERWENT LUMBAR ARTHRODESIS AND HAD A MINIMUM 3-MONTH FOLLOW-UP. DATA WAS EXTRACTED FROM CHARTS AND HOSPITAL RECORDS. THERE WERE 107 PATIENTS WHO UNDERWENT BILATERAL PEDICLE SCREW FIXATION USING TRADITIONAL LATERAL INSERTION TECHNIQUE (LATERAL GROUP) AND 314 PATIENTS WHO UNDERWENT BILATERAL PEDICLE SCREW FIXATION USING THE NEW MEDIAL TRAJECTORY INSERTION TECHNIQUE (MEDIAL GROUP). WOUND INFECTION FOLLOWING AN L3-S1 FUSION WITH LATERAL SCREW TRAJECTORY WAS OBSERVED IN THIS PATIENT WITH A PREOPERATIVE DIAGNOSIS OF FAILED LAMINECTOMY. NO OTHER DETAILS WERE MENTIONED.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) CE INFUSOR LV 2 DEVICE WAS OBSERVED LEAKING AT THE LOCATION OF THE INJECTION SITE DURING USE. THERE IS NO PATIENT INJURY OR MEDICAL INTERVENTION REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CE INFUSOR LV 2, 12 PACK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 09N058

    Patients

    Seq Age Sex Outcome Treatment
    1