BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SWAN-GANZ CONTINUOUS CARDIAC CATHETER

    MDR report key: 2333568 · Received November 11, 2011

    Report

    Report Number
    2015691-2011-16413
    Event Type
    Malfunction
    Date Received
    November 11, 2011
    Date of Event
    September 12, 2011
    Report Date
    October 14, 2011
    Manufacturer
    EDWARDS LIFESCIENCES, PR
    Product Code
    KRA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WAS RECEIVED FROM THE REPORTING HOSPITAL'S DEPARTMENT OF PREVENTIVE MEDICINE, WHICH STATED: THE RESEARCH GROUP HAS NOT CONSIDERED AT ANY TIME THAT THE CATHETERS ARE RELATED (TO THE PATIENT'S INFECTIONS) FROM THE POINT OF VIEW OF A PRODUCT DEFECT. THE RESULTS BASED ON MICROBIOLOGICAL TECHNIQUES, IN ALL THE AREAS OF THE RESEARCH HAVE BEEN NEGATIVE TO THE CAUSAL AGENT INVESTIGATED, IN RESPONSE TO THE POSSIBILITY TO CONFIRM OR TO RULE OUT THE CONTAMINATION OF THE MENTIONED CATHETERS. TO DATE, THE RESULTS OF CURRENT RESEARCH DO NOT PERMIT US TO IDENTIFY A SPECIFIC FOCUS IN OUR HOSPITAL. THE OPTION HAS BEEN TO EXTREME THE MEASURES OF HYGIENE IN THE HEALTH CARE.

    Additional Manufacturer Narrative · 1

    NO PRODUCT IS EXPECTED FOR RETURN. EXACT LOT NUMBERS WERE NOT AVAILABLE BUT POTENTIAL LOT NUMBERS WERE PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED AFTER THE STERILIZATION RECORDS OF THESE LOTS ARE REVIEWED. THIS REPORT REPRESENTS ONE EVENT OF THE EIGHT REPORTED. TWO MODEL NUMBERS WERE IDENTIFIED (139HF75P AND 744HF75); 510K NUMBERS K924661 (KRA) AND K924452 (DYG).

    Additional Manufacturer Narrative · 1

    NO PRODUCTS WERE RETURNED FOR TESTING. A REVIEW OF THE STERILIZATION RECORDS OF THE MULTIPLE POTENTIAL LOT NUMBERS FOUND NO DISCREPANCIES. HOSPITAL ACQUIRED ACINETOBACTER INFECTIONS HAVE BEEN WELL DOCUMENTED IN THE LITERATURE. CLINICAL SOURCES THAT HAVE BEEN IDENTIFIED INCLUDE MATERIALS USED FOR RESPIRATORY THERAPY OR SUPPORT, AIR HUMIDIFIERS, INADEQUATE DECONTAMINATION OF RESPIRATORY MONITORING DEVICES AND RESUSCITATION BAGS, AND OTHERS. ETHYLENE OXIDE STERILIZATION HAS BEEN SHOWN TO BE AN EFFECTIVE METHOD OF KILLING THIS TYPE OF BACTERIA; THESE CATHETERS ARE STERILIZED BY ETHYLENE OXIDE IN A VALIDATED PROCESS. THE PRODUCT IFU LISTS SEPSIS/INFECTION AS A POTENTIAL COMPLICATION AND PREVENTIVE MEASURES ARE RECOMMENDED TO GUARD AGAINST INFECTION, INCLUDING THE USE OF STERILE TECHNIQUE, APPLICATION OF TOPICAL ANTIBIOTIC OINTMENT, AND FREQUENT DRESSING CHANGES. THE DURATION OF CATHETERIZATION SHOULD BE THE MINIMUM REQUIRED BY THE PATIENT'S CLINICAL STATE SINCE THE RISK OF THROMBOEMBOLIC AND INFECTIOUS COMPLICATIONS INCREASES WITH TIME. REVIEW OF THE AVAILABLE INFORMATION SUGGESTS THAT CLINICAL FACTORS WERE THE MOST LIKELY CAUSE OF THE INFECTIONS REPORTED, RATHER THAN THE CATHETERS, THEMSELVES. NO ACTIONS WILL BE TAKEN AT THIS TIME.

    Description of Event or Problem · 1

    AS REPORTED FROM A HOSPITAL ANESTHESIA DEPARTMENT IN SPAIN, EIGHT PATIENTS WERE INFECTED WITH THE BACTERIA ACINETOBACTER; FOUR OF THEM DIED. THE COMMON FACTOR DETERMINED BY THE REPORTING PHYSICIAN WAS THAT THEY ALL HAD A SWAN-GANZ INSERTED; THE TYPE OF INTRODUCER HAS NOT BEEN CONFIRMED. THE HOSPITAL DEPARTMENT OF PREVENTIVE MEDICINE NOTED THAT A CULTURE WOULD BE DONE TO FIND OUT MORE DETAILS ABOUT THE POTENTIAL RELATIONSHIP BETWEEN THE CATHETERS AND THE PATIENT'S INFECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SWAN-GANZ CONTINUOUS CARDIAC CATHETER CONTINOUS CARDIAC OUPTUT THERMODILUTION CATHETER KRA EDWARDS LIFESCIENCES, PR SWAN GANZ UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization