BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ZOLL IVTM QUATTRO CATHETER

    MDR report key: 6296709 · Received February 2, 2017

    Report

    Report Number
    3010617000-2017-00084
    Event Type
    Malfunction
    Date Received
    February 2, 2017
    Date of Event
    September 21, 2015
    Report Date
    February 1, 2017
    Manufacturer
    ZOLL CIRCULATION
    Product Code
    NCX
    UDI-DI
    00849111075121
    PMA / PMN Number
    K101987
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SP
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    SINCE THERE WERE NO DEVICE DEFICIENCIES REPORTED BY THE SITE, THE DEVICE ASSOCIATED WITH THIS COMPLAINT WILL NOT BE RETURNED TO ZOLL FOR PHYSICAL EVALUATION. BASED ON THE INFORMATION PROVIDED BY THE SITE, THERE WAS NO DEVICE DEFICIENCIES REPORTED. ACCORDING TO THE SITE, EVENT WAS A PNEUMONIA IN POST CARDIAC ARREST PATIENT, WHO WAS ON VENTILATOR. THE SITE REPORTED THAT EVENT WAS RELATED TO THE PATIENT'S CLINICAL CONDITION, AND NOT RELATED TO STUDY DEVICE OR STUDY PROCEDURE. VENTILATOR-ASSOCIATED PNEUMONIA IS A KNOWN COMPLICATION DURING HOSPITAL STAY, ESPECIALLY IN IMMOBILIZE INTUBATED PATIENTS. RECENT DATA ANALYSIS OF (B)(4) TRIALS, WHICH ENROLLED 1885 PATIENTS, SUPPORTS THE CONCLUSION THAT TM DOES NOT INCREASE RATE OF PNEUMONIA DURING HOSPITAL STAY (1). (1.CROSSLEY S, REID J, MCLATCHIE R, HAYTON J, CLARK C, MACDOUGALL M, ANDREWS PJ. A SYSTEMATIC REVIEW OF THERAPEUTIC HYPOTHERMIA FOR ADULT PATIENTS FOLLOWING TRAUMATIC BRAIN INJURY.CRIT CARE. 2014 APR 17;18(2):R75. GEORGIOU AP1, MANARA AR. ROLE OF THERAPEUTIC HYPOTHERMIA IN IMPROVING OUTCOME AFTER TRAUMATIC BRAIN INJURY: A SYSTEMATIC REVIEW. BR J ANAESTH. 2013 MAR;110(3):357-67.) A LITERATURE REVIEW LED TO A CONCLUSION THAT TH DID NOT INCREASE PNEUMONIA RATES IN OHCA PATIENTS. A SYSTEMATIC REVIEW OF ADVERSE EVENTS IN PATIENTS UNDERGOING THERAPEUTIC HYPOTHERMIA AFTER CARDIAC ARREST DEMONSTRATED THAT TH WAS ASSOCIATED WITH REDUCED IN-HOSPITAL MORTALITY, MORTALITY AT 1 MONTH, AND MORTALITY AT 6 MONTHS. THERE IS A TREND OF A HIGHER RATE OF PNEUMONIA IN THE HYPOTHERMIA GROUPS THAN IN THE NORMOTHERMIA GROUPS (RR, 1.18, 95% CI, 0.99 TO 1.40, P=0.06; I2=30%). HOWEVER, THE TREND WAS ONLY OBSERVED IN EARLIER TRIALS (BEFORE 2006) AND WAS NOT CONFIRMED IN LATER TRIALS (AFTER 2006). THIS MAY BE DUE TO THE ADVANCEMENT IN GENERAL OHCA POST-HOSPITAL MANAGEMENT WITH TIME, AN EVOLVING TH PROTOCOL AS THE TECHNOLOGY WAS DEVELOPED AND IMPROVED, AND/OR BETTER TRIAL DESIGNS TO REDUCE BIAS IN THE LATER TRIALS (2). IN THE RECENT TARGETED TEMPERATURE MANAGEMENT AT 33°C VERSUS 36°C AFTER CARDIAC ARREST TRIAL (TTM), NO DIFFERENCE WAS OBSERVED FOR THE RATES OF PNEUMONIA AT TWO DIFFERENT TARGET TEMPERATURES (52% VS. 46%, P=0.089) IN UNCONSCIOUS SURVIVORS OF OUT-OF-HOSPITAL CARDIAC ARREST OF PRESUMED CARDIAC CAUSE (3). (2.XIAO G, GUO Q, SHU M, XIE X, DENG J, ZHU Y, WAN C. SAFETY PROFILE AND OUTCOME OF MILD THERAPEUTIC HYPOTHERMIA IN PATIENTS FOLLOWING CARDIAC ARREST: SYSTEMATIC REVIEW AND META-ANALYSIS. EMERG MED J. 2013 FEB;30(2):91-100.) (3.NIELSEN N, WETTERSLEV J, CRONBERG T, ERLINGE D, GASCHE Y, HASSAGER C, HORN J, HOVDENES J, KJAERGAARD J, KUIPER M, PELLIS T, STAMMET P, WANSCHER M, WISE MP, ÅNEMAN A, AL-SUBAIE N, BOESGAARD S, BRO-JEPPESEN J, BRUNETTI I, BUGGE JF, HINGSTON CD, JUFFERMANS NP, KOOPMANS M, KØBER L, LANGØRGEN J, LILJA G, MØLLER JE, RUNDGREN M, RYLANDER C, SMID O, WERER C, WINKEL P, FRIBERG H; TTM TRIAL INVESTIGATORS. TARGETED TEMPERATURE MANAGEMENT AT 33°C VERSUS 36°C AFTER CARDIAC ARREST. N ENGL J MED. 2013 DEC 5;369(23):2197-206.) LITERATURE SEARCH ALSO SHOWED THAT PNEUMONIA DID NOT IMPACT MORTALITY AND NEUROLOGICAL OUTCOME IN OHCA PATIENT. EARLY-ONSET PNEUMONIA IS A COMMON COMPLICATION AFTER SUCCESSFUL CARDIOPULMONARY RESUSCITATION REGARDLESS OF HYPOTHERMIA TREATMENT. THE ONSET OF PNEUMONIA MAY INCREASE THE LENGTH OF MECHANICAL VENTILATION DURATION AND INTENSIVE CARE UNIT STAY, BUT ITS INFLUENCE ON SURVIVAL AND NEUROLOGICAL OUTCOME IS MARGINAL15, 16. PROPHYLACTIC ANTIBIOTICS WERE ASSOCIATED WITH A REDUCED INCIDENCE OF PNEUMONIA BUT A SIMILAR RATE OF GOOD FUNCTIONAL OUTCOME (4). (4.GAGNON DJ, NIELSEN N, FRASER GL, RIKER RR, DZIODZIO J, SUNDE K, HOVDENES J, STAMMET P, FRIBERG H, RUBERTSSON S, WANSCHER M, SEDER DB. PROPHYLACTIC ANTIBIOTICS ARE ASSOCIATED WITH A LOWER INCIDENCE OF PNEUMONIA IN CARDIAC ARREST SURVIVORS TREATED WITH TARGETED TEMPERATURE MANAGEMENT. RESUSCITATION. 2015 JUL;92:154-9.)

    Description of Event or Problem · 1

    A (B)(6) -YEAR OLD FEMALE WAS ENROLLED IN THE FROST STUDY ON (B)(6) 2015 AT 15:26 WITH A PAST MEDICAL HISTORY OF HYPERTENSION, CORONARY ARTERY DISEASE, SIGNIFICANT VALVULOPATHY, MOST RECENT PCI ON (B)(6) 20016, EPISODE OF MYOCARDIAL INFARCTION ON (B)(6) 2002, HEART FAILURE, DIABETES, TRANSIENT ISCHEMIC ATTACK APPROXIMATELY 2010 (UNKNOWN DATE AND MONTH), GI BLEED IN (B)(6) 2006 AND (B)(6). THE PATIENT HAD A CARDIAC VALVE SURGERY ON (B)(6) 1974. THE PATIENT NEVER USED TOBACCO OR ALCOHOL. ON (B)(6) 2015 THE PATIENT HAD A WITNESSED OUT OF OFFICE CARDIAC ARREST AT 12:57 AT HOME. BEFORE EMS ARRIVAL SHE RECEIVED BYSTANDER CHEST COMPRESSIONS AND VENTILATION AT 13:02, DEFIBRILLATIONS AT 13:03. EMS ARRIVED AT 13:25. THE PATIENT WAS INTUBATED. ROSC WAS ACHIEVED AT 13:30. AT ADMISSION A PULSE RATE OF 67 BEATS PER MINUTE, RESPIRATORY RATE OF 18 BREATHS PER MIN, AND BP VALUE OF 91/60 MM HG WERE RECORDED. ON THE SAME DAY OF (B)(6), IVTM QUATTRO CATHETER WAS INSERTED INTO THE RIGHT FEMORAL VEIN AT 17:00 SUCCESSFULLY AND COOLING WAS INITIATED AT 20:00. REWARMING PROCEDURE BEGAN ON (B)(6) 2015 AT 20:00. CATHETER WAS REMOVED ON (B)(6) 2015 AT 10:00. ON (B)(6) 2015 AT 2:00, 6 HOURS POST INITIATION OF COOLING PROCEDURE, 18 HOURS PRIOR TO REWARMING PROCEDURE AND 2 DAYS PRIOR TO CATHETER REMOVAL, THE PATIENT EXPERIENCED PNEUMONIA. THE PATIENT WAS ON INTUBATION FOR 6 DAYS FROM (B)(6) 2015. VITAL SIGNS WERE COLLECTED AT THE TIME OF REWARMING INITIATION ON AT 20:00 ON (B)(6) AND PULSE RATE OF 72 BEATS PER MIN, A BP VALUE OF 116/53 MMHG AND, RESPIRATORY RATE OF 22 BREATHS PER MIN WERE RECORDED. THE PATIENT WAS TREATED WITH INVASIVE MECHANICAL VENTILATION AND WITH MEDICATIONS. EVENT WAS RESOLVED WITHOUT SEQUELAE ON (B)(6) 2016 AT 22:00. ON (B)(6) 2015, 19 DAYS POST ENROLLMENT, SHE WAS DISCHARGED TO INDEPENDENT FAMILY SUPPORT IN STABLE CONDITION. ON (B)(6) 2015 PATIENT COMPLETED 90 DAY FOLLOW UP SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81254 ZOLL IVTM QUATTRO CATHETER CENTRAL VENOUS CATHETER NCX ZOLL CIRCULATION IC-4593 UNKNOWN 00849111075121

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Other| R