BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INTEGRATED APD SET W/CASSETTE3-PRONG

    MDR report key: 1801879 · Received August 16, 2010

    Report

    Report Number
    1423500-2010-02544
    Event Type
    Malfunction
    Date Received
    August 16, 2010
    Date of Event
    July 25, 2010
    Report Date
    July 25, 2010
    Manufacturer
    BAXTER HEALTHCARE - MOUNTAIN HOME
    Product Code
    FKX
    PMA / PMN Number
    K923065
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS COMPLAINT FOR A SYSTEM ERROR 2240 (AIR IN SET) WHICH OCCURRED DURING FILL 1 OF 4 WAS NOT CONFIRMED DUE TO A LACK OF SAMPLE. THE CAUSE WAS UNDETERMINED. THE BATCH REVIEW WAS NOT PERFORMED BECAUSE THE LOT NUMBER IS UNKNOWN. THE LABEL REVIEW FOUND THE LABELING ADEQUATE FOR THE POTENTIAL USE ERROR IN THIS COMPLAINT. BAXTER HAS CONDUCTED A TREND REVIEW AND FOUND THAT SIMILAR REPORTS HAVE BEEN RECEIVED FOR THE REPORTED PROBLEM. THE ROOT CAUSE INVESTIGATION IS IN PROGRESS THROUGH (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE WAS DISCARDED. IF ADDITIONAL INFORMATION BECOMES AVAILABLE, THEN A FOLLOW UP MDR WILL BE SUBMITTED.

    Description of Event or Problem · 1

    ACCORDING TO THE PUBLICATION, SURGICAL SITE INFECTION ASSOCIATED WITH THE USE OF BOVINE SERUM ALBUMIN-GLUTARALDEHYDE SURGICAL ADHESIVE (BIOGLUE) IN CRANIAL SURGERY: A CASE CONTROL STUDY, BIOGLUE WAS USED IN SEVERAL CRANIAL PROCEDURES TO OBTAIN A WATER-TIGHT CLOSURE OF THE DURA MATER. IF THE DURAL DEFECT WAS VERY SMALL, BIOGLUE ALONE WAS APPLIED ON A PATCH OF SURGICEL (JOHNSON AND JOHNSON MEDICAL), IF THE DEFECT WAS LARGER DURAPLASTY WAS USED WITH SUTURE EITHER ALONE OR WITH BIOGLUE. SURGEONS USED UPPERMOST AUTOGRAFT, BUT IF NOT AVAILABLE IN THE DESIRED QUANTITY AND SHAPE NEUROPATCH (AESCULAP, INC.) WAS USED. A CASE-CONTROL STUDY OF PATIENTS WHO UNDERWENT CRANIOTOMY IN THE DEPARTMENT OF NEUROSURGERY AT (B)(6) HOSPITAL WAS CARRIED OUT FROM (B)(6) 2006 TO (B)(6) 2007. SUPRA- OR INFRATENTORIAL CRANIOTOMY PROCEDURES ARE INCLUDED IN THIS CASE STUDY WHILE BURR HOLE OPERATIONS AND SHUNT PROCEDURES ARE EXCLUDED. THE DATA WAS RETROSPECTIVELY REVIEWED BY TWO INDEPENDENT INVESTIGATORS. THERE ARE TWO CONTROLS PER EACH CASE, CONTROLS WERE NOT MATCHED AND WERE RANDOMLY DETERMINED BASED ON POSTOPERATIVE REPORTS. THE CASE GROUP CONSISTED OF 30 PATIENTS WHO DEVELOPED A SURGICAL SITE INFECTION (SSI) AND THE CONTROL GROUP CONSISTED OF 60 PATIENTS WHO DID NOT DEVELOP AN SSI. BIOGLUE WAS USED IN 13 PATIENTS IN THE CASE GROUP (43.3%), 12 OF THESE 13 PATIENTS ALSO RECEIVED NEUROPATCH. FOUR OF THE PATIENTS IN THE CONTROL GROUP RECEIVED BIOGLUE (6.7%), TWO OF THESE FOUR PATIENTS ALSO RECEIVED NEUROPATCH. THE CASE REPORT CONCLUDED THAT BIOGLUE AS A DURAL SEALANT HAS A STRONG STATISTICAL ASSOCIATION WITH THE OCCURRENCE OF SSI IN CRANIOTOMY (P=0.007). TWO OTHER RISK FACTORS WERE ALSO DETERMINED: SURGERY LENGTH AND AVERAGE YOUNGER AGE. HOWEVER, THE CASE REPORT ALSO WARNS AGAINST A POSSIBLE BIAS IN THEIR RESULTS. CONTROLS WERE NOT MATCHED ACCORDING TO KNOWN RISK FACTORS OF SSI, BIOGLUE USE COULD BE A CONFOUND BIAS SINCE THE TYPES OF SURGERY MOST ASSOCIATED WITH SSI AND THE ONES THAT MOST OFTEN REQUIRE DURAPLASTY, AND CSF LEAKAGE WAS NOT INCLUDED IN THEIR ANALYSIS DUE TO LACK OF DATA. THE STUDY SUGGESTS THAT BIOGLUE CAN BE AN INDEPENDENT RISK FACTOR OF SSI ACCORDING TO CSF LEAKAGE OR SOME SPECIFIC KIND OF SURGERY (E.G. CRANIAL BASE SURGERY). CAEN UNIVERSITY HOSPITAL NOTICED A SUBSTANTIAL INCREASE OF SSI INCIDENCE (5.4% VS 1%) IN THEIR UNIT WHEN BIOGLUE WAS USED AND A RETURN TO NORMAL RATES WHEN USE OF BIOGLUE WAS STOPPED. THEY ALSO STATED THAT NO CHANGES OTHER THAN NOT USING BIOGLUE WERE MADE. (B)(6) STATES THE RESULTS OF THEIR INVESTIGATION SHOW THAT BIOGLUE RAISES THE RISK OF SSI IN PATIENTS UNDERGOING CRANIOTOMY, PROBABLY BECAUSE IT TRIGGERS BOTH INTENSE ACUTE AND CHRONIC INFLAMMATORY RESPONSE. SINCE THEIR RESULTS HAVE BEEN KNOWN, THEY HAVE REDUCED THEIR USE OF BIOGLUE SINCE THEY CONSIDER THE RISK OF INFECTION TO BE TOO HIGH.

    Description of Event or Problem · 1

    A CUSTOMER CONTACTED BAXTER'S TECHNICAL SERVICE CENTER REGARDING A SYSTEM ERROR 2240 (AIR IN SET) ALARM ON THE HOMECHOICE DURING FILL 1 OF 4. HOME PATIENT (HP) STATED A CLAMP WAS OPEN ON ONE OF THE LINES. THE TECHNICAL SERVICE REPRESENTATIVE (TSR) EXPLAINED THE ALARM AND SUGGESTED HP START OVER WITH NEW SUPPLIES BUT HP STATED SHE NEEDED TO GO TO SLEEP. TSR SUGGESTED TO CONTACT THE NURSE ABOUT THE PROBLEM AND ASSISTED TO END THERAPY. PROPER PROCEDURES PER THE USER MANUAL REVIEWED WITH THE CALLER. NO PATIENT INJURY OR MEDICAL INTERVENTION WAS REPORTED AT THE TIME OF THE INITIAL REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INTEGRATED APD SET W/CASSETTE3-PRONG SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX BAXTER HEALTHCARE - MOUNTAIN HOME

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR