BEUDAMED
    FDA Adverse Event Death Summary report: N

    LIBERTY CYCLER SET, SINGLE CONN./EXT.DL

    MDR report key: 4962997 · Received July 31, 2015

    Report

    Report Number
    8030665-2015-00339
    Event Type
    Death
    Date Received
    July 31, 2015
    Date of Event
    July 26, 2015
    Report Date
    July 26, 2015
    Manufacturer
    REYNOSA MANUFACTURING
    Product Code
    FKX
    PMA / PMN Number
    K043363
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION, AND THE FAILURE MODE CANNOT BE CONFIRMED. HOWEVER, AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. A SEARCH WAS CONDUCTED TO IDENTIFY THE LOTS OF PRODUCT SHIPPED TO THE CUSTOMER THREE MONTHS PRIOR TO THE EVENT. THERE WERE NO DEVIATIONS OR NON-CONFORMANCES DURING THE MANUFACTURING PROCESS. IN ADDITION, THE DEVICE RECORD REVIEW CONFIRMED THE LABELING, MATERIAL, AND PROCESS CONTROLS WERE WITHIN SPECIFICATION.

    Additional Manufacturer Narrative · 1

    MEDICAL RECORDS WERE REVIEWED BY POST MARKET SURVEILLANCE STAFF. BASED ON THE 14 PAGES OF MEDICAL RECORDS INFORMATION IT APPEARS THAT ON (B)(6) 2015, THIS (B)(6) MALE PATIENT EXPIRED FROM CARDIAC ARREST. CAUSE OF THE CARDIAC ARREST IS UNKNOWN BUT MEDICAL RECORDS REVEAL THAT HYPERKALEMIA MAY HAVE BEEN THE CAUSE LAB WORK PERFORMED ON (B)(6) 2015 SHOWS POTASSIUM LEVEL WAS NORMAL. PATIENT'S WIFE MENTIONED THAT THE PATIENT DID NOT FEEL GOOD DURING THE DAY AND MAY HAVE HAD SOME VAGUE CHEST DISCOMFORT BEFORE THE EVENT. MEDICAL RECORDS DO NOT CONTAIN DIALYSIS TREATMENT RECORDS FOR THE TIME OF THIS EVENT. ACCORDING TO THE PERITONEAL DIALYSIS REGISTERED NURSE (PDRN), THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO CARDIAC ARREST DURING THE INITIAL DRAIN AFTER REPORTING DIFFICULTY BREATHING PDRN STATED THE PATIENT HAD A HISTORY OF CARDIAC-RELATED ISSUES. MEDICAL RECORDS CONFIRM THE PATIENT HAD A CORONARY ARTERY BYPASS GRAFT IN (B)(6) 2013 AND A HISTORY OF HYPERTENSION. THE PDRN STATED THE PATIENT EXPIRED IN THE AMBULANCE WHILE BEING TRANSPORTED TO THE HOSPITAL. THE PDRN PROVIDED THE LAST KNOWN DRY WEIGHT AS (B)(6). ACCORDING TO THE MEDICAL RECORDS, THE PATIENT'S INITIAL DIAGNOSIS WAS RESPIRATORY ARREST ESRD DEATH NOTIFICATION LISTS THE PRIMARY CAUSE OF DEATH AS CARDIAC ARREST WITH NO SECONDARY CAUSES. MOST RECENT BICARBONATE LEVELS ON (B)(6) 2015 WERE NORMAL. MEDICAL RECORDS DID NOT CONTAIN AN AUTOPSY REPORT OR A DEATH CERTIFICATE. MEDICAL RECORDS DID NOT CONTAIN LABORATORY RESULTS FROM (B)(6) 2015 FOR REVIEW. MEDICAL RECORDS DID NOT CONTAIN EMERGENCY MEDICAL SERVICE PROGRESS NOTES FOR REVIEW CONSIDERING THE PATIENT COMPLAINT OF VAGUE CHEST PAIN DURING THE DAY, IT APPEARS THE PATIENT WAS POSSIBLY EXPERIENCING A CARDIAC EPISODE PRIOR TO THE INITIATION OF PERITONEAL DIALYSIS. MEDICAL RECORDS DID NOT INDICATE A CAUSAL RELATIONSHIP BETWEEN THE PATIENT'S DIALYSIS TREATMENT AND THE PATIENT'S DEATH.

    Additional Manufacturer Narrative · 1

    THE DEVICE HAS NOT BEEN RETURNED FOR EVALUATION AT THIS TIME AND WILL NOT BE AVAILABLE FOR EVALUATION. THIS REPORT IS BEING SUBMITTED AS PART OF A SYSTEM LEVEL REVIEW; WHICH WILL INCLUDE AN INVESTIGATION OF ALL POTENTIAL FRESENIUS PRODUCTS BEING USED AT THE TIME OF THE EVENT.

    Description of Event or Problem · 1

    A PERITONEAL DIALYSIS (PD) PATIENT'S SPOUSE CONTACTED TECHNICAL SERVICES AND INDICATED THE PD PT HAD EXPIRED DURING DRAIN 0 WHILE COMPLETING DIALYSIS TREATMENT. FOLLOW UP WAS MADE WITH THE PD PT'S CLINIC REGISTERED NURSE (RN), WHO CONFIRMED THE PT EXPIRED ON (B)(6) 2015 DUE TO CARDIAC ARREST DURING THE INITIAL DRAIN AFTER REPORTING DIFFICULTY BREATHING. THE NURSE STATED THE PT HAD A HISTORY OF CARDIAC-RELATED ISSUES AND STATED THE PT EXPIRED IN THE AMBULANCE WHILE BEING TRANSPORTED TO THE HOSPITAL. NO ADDITIONAL INFO WAS PROVIDED. MEDICAL RECORDS WERE REQUESTED.

    Description of Event or Problem · 1

    MEDICAL RECORDS WERE PROVIDED BY THE PATIENT'S DIALYSIS CENTER. THE PATIENT WAS A (B)(6) MALE WHO WAS HAVING DIFFICULTY BREATHING ON (B)(6) 2015 EMERGENCY MEDICAL SERVICES (EMS) WAS CALLED. WHILE IN THE AMBULANCE, THE PATIENT WAS IN ASYSTOLE. EMS INTUBATED THE PATIENT AND ADMINISTERED BIPAP. IN ADDITION, THE PATIENT RECEIVED 3 ROUNDS OF EPINEPHRINE INTRAVENOUSLY AND ONE DEFIBRILLATION FOR VENTRICULAR FIBRILLATION. THE PATIENT ARRIVED AT THE HOSPITAL IN RESPIRATORY ARREST AND CARDIAC ARREST. THE PATIENT HAD NO SIGNS OF LIFE AND NO HEART TONES IN THE EMERGENCY ROOM, ADVANCED CARDIAC LIFE SUPPORT (ALCS) WAS CONTINUED PATIENT WAS ADMINISTERED BICARBONATE EPINEPHRINE ALONG WITH CARDIOPULMONARY RESUSCITATION (CPR) AND BAGGING DESPITE MULTIPLE ROUNDS OF MEDICATIONS AND CPR, THE PATIENT HAD A VERY SLOW ASYSTOLE, NO HEART TONES, NO PULSE AND AFTER NEARLY 50 MINUTES OF ALCS MEASURES, PATIENT WAS PRONOUNCED DEAD AT 02:58. PATIENT EXPIRED AT THE HOSPITAL ON (B)(6) 2015. DEATH NOTIFICATION REVEALED PATIENT'S PRIMARY CAUSE OF DEATH WAS CARDIAC ARREST OF UNKNOWN CAUSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    499008 LIBERTY CYCLER SET, SINGLE CONN./EXT.DL FKX REYNOSA MANUFACTURING NA

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Death| L| O| R DELFLEX PD SOLUTION