BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY CYCLER

    MDR report key: 6637811 · Received June 13, 2017

    Report

    Report Number
    2937457-2017-00455
    Event Type
    Injury
    Date Received
    June 13, 2017
    Date of Event
    May 10, 2017
    Report Date
    June 21, 2017
    Manufacturer
    CONCORD MANUFACTURING
    Product Code
    FKX
    UDI-DI
    00840861100972
    PMA / PMN Number
    K123630
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS ON 05/18/2017. A VISUAL INSPECTION CYCLER EXTERIOR FOUND TWO CRACKS APPROXIMATELY 2.5¿ LEFT AND RIGHT OF CENTER ON THE TOP OF THE FRONT PANEL ¿ BEZEL EMI SHIELD. NO OTHER PHYSICAL DAMAGE WAS FOUND. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE VALVE ACTUATION TEST AND THE SYSTEM AIR LEAK TEST PASSED. AN INTERNAL INSPECTION OF THE CYCLER FOUND PNEUMATIC FILTER HP2 DISCOLORED. THE CAUSE OF THE OBSERVED DISCOLORATION COULD NOT BE DETERMINED. THE MUSHROOM HEAD CHECK PASSED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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

    THE DEVICE WAS RETURNED FOR FAILURE ANALYSIS ON (B)(6) 2017. A VISUAL INSPECTION CYCLER EXTERIOR FOUND TWO CRACKS APPROXIMATELY 2.5¿ LEFT AND RIGHT OF CENTER ON THE TOP OF THE FRONT PANEL ¿ BEZEL EMI SHIELD. NO OTHER PHYSICAL DAMAGE WAS FOUND. A SIMULATED TREATMENT WAS PERFORMED AND COMPLETED WITHOUT ANY FAILURES OR PROBLEMS. THE VALVE ACTUATION TEST AND THE SYSTEM AIR LEAK TEST PASSED. AN INTERNAL INSPECTION OF THE CYCLER FOUND PNEUMATIC FILTER HP2 DISCOLORED. THE CAUSE OF THE OBSERVED DISCOLORATION COULD NOT BE DETERMINED. THE MUSHROOM HEAD CHECK PASSED. AN INVESTIGATION OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED BY THE MANUFACTURER. 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. A POSSIBLE TEMPORAL RELATIONSHIP EXISTS WITH THE FRESENIUS PRODUCTS AND CCPD TREATMENTS AND THE REPORTED EVENTS OF CONFUSION, ALTERED MENTAL STATUS, THRASHING AROUND, COGNITIVE IMPAIRMENT, SEVERE AGITATION, HIGH BUN AND CREATININE AND SUBSEQUENT INPATIENT HOSPITALIZATION. THERE IS A POSSIBLE CAUSAL RELATIONSHIP BETWEEN THE PATIENT¿S CURRENT PD TREATMENT PLAN AND THE PATIENT BEING DISCHARGED TO HOME WITH CONTINUING CONFUSION AND ALTERED MENTAL STATUS. THIS PATIENT REQUIRED A SECOND INPATIENT ADMISSION ON (B)(6) 2017 FOR ALTERED MENTAL STATUS AND ADDITIONALLY HAS BEEN TRANSITIONED TO IN HOSPITAL HEMODIALYSIS (HD) WHICH IS ADDRESSED IS REPORTED UNDER MFR # 2937457-2017-00462.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED BY A PERITONEAL DIALYSIS REGISTERED NURSE (PDRN) THAT THIS PATIENT WITH END STAGE RENAL DISEASE (ESRD) ON CONTINUOUS CYCLIC PERITONEAL DIALYSIS (CCPD) THERAPY SINCE (B)(6) 2013 WAS EXPERIENCING CONFUSION, ALTERED STATE OF CONSCIOUSNESS OF UNKNOWN ETIOLOGY, POSSIBLE ELECTROLYTE IMBALANCE AND REQUIRED IN-PATIENT HOSPITALIZATION (B)(6) 2017. THIS PATIENT WHO PERFORMS PD AT HOME WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES (EMS) AMBULANCE FROM HOME TO EMERGENCY ROOM (ER) WITH FAMILY MEMBERS FOR ALTERED MENTAL STATUS EXHIBITING CONFUSION AND AGITATION. PER EMS MEDICS THE PATIENT KEPT SPEAKING TO SOMEONE WHO WAS NOT THERE AND THAT THE PATIENT¿S FAMILY STATED HER AMMONIA LEVEL MAY BE INCREASED BECAUSE THIS HAS HAPPENED IN THE PAST. FURTHERMORE, THE FAMILY STATED THAT RAMBLING AND CONFUSION IS NOT THE NORMAL FOR THE PATIENT. THE PATIENT DID NOT HAVE HEADACHE, FEVER, OR CHILLS. UPON ER ARRIVAL THE PATIENT ANSWERED QUESTIONS APPROPRIATELY BUT CONTINUING TO SPEAK TO HERSELF. THE PATIENT PRESENTED WITH PROGRESSING AGITATION, CONFUSION AND THRASHING AROUND WITH NO OTHER ASSOCIATED SYMPTOMS. DURING ER EVALUATION PATIENT WAS ADMINISTERED BENZODIAZEPINE IN AN ATTEMPT TO CONTROL AGITATION SUFFICIENTLY TO EXPEDITE CT SCAN EVALUATION, (NEGATIVE WORK UP) AND LUMBAR PUNCTURE (LP) TO RULE OUT MENINGITITS. FOLLOWING LP, PATIENT APPEARED TO IMPROVE BECOMING MORE ALERT, COHERENT, WITH ACCOMPANYING DROWSINESS FROM RECEIVING BENZODIAZEPINE (ATIVAN ONE TIME INTRAVENOUS PUSH (IV )PUSH ) AND HALDOL. ADDITIONALLY THE PATIENT WAS PLACED ON EMPIRIC TRIPLE ANTIBIOTICS DURING ER EVALUATION, VANCOMYCIN, CEFTRIAXONE AND CLINDAMYCIN. VITAL SIGNS ON EVALUATION (B)(6) 2017 INCLUDED: TEMPERATURE: 98.8(ORAL) PULSE:101 (HIGH) RESPIRATORY RATE 18; SYSTOLIC BP:152 (HIGH); DIASTOLIC BP: 112 9HIGH), MEAN ARTERIAL PRESSURE( MAP )125 MILLIMETERS OF MERCURY (MMHG); PULSE OXIMETRY 95% . FURTHERMORE, A 12 POINT REVIEW OF SYSTEMS WAS PERFORMED AND SHOWED PERTINENT POSITIVES AND NEGATIVES ARE PER HISTORY OF PRESENT ILLNESS, OTHERWISE NEGATIVE. LABORATORY TESTING AND ADDITIONAL DIAGNOSTICS WERE ALSO PERFORMED AS PART OF THE INITIAL AND ONGOING EVALUATION AND ARE NOTED SUBSEQUENTLY IN THIS REPORT. THE PATENT WAS ADMITTED AND DURING HOSPITAL COURSE THE PATIENT RECEIVED BENZODIAZEPINES TO TREAT AND STABILIZE AGITATION, HAD PD THERAPY, AND WAS TREATED WITH NORMAL SALINE TO IMPROVE SODIUM. FURTHERMORE, THE PATIENT RECEIVED HYPERTENSIVE MEDICATIONS TO CONTROL BLOOD PRESSURE (HISTORY OF HYPERTENSION) AND CALCITRIOL WAS DISCONTINUED AND HYPERCALCEMIA WAS CORRECTED. THE PATIENT¿S CONFUSION AND MENTAL STATUS IMPROVED AND WAS DISCHARGED ON (B)(6) 2017 WITH A PLAN TO FOLLOW UP WITH NEPHROLOGIST AT PD CLINIC AND RESUME PD THERAPY AT HOME.

    Description of Event or Problem · 1

    ON (B)(6) 2017, IT WAS REPORTED BY A PERITONEAL DIALYSIS (PD) PATIENT'S REGISTERED NURSE (RN) THAT THIS PD PATIENT WAS EXPERIENCING CONFUSION, ALTERED STATE OF CONSCIOUSNESS OF UNKNOWN ETIOLOGY, POSSIBLE ELECTROLYTE IMBALANCE AND REQUIRED IN-PATIENT HOSPITALIZATION FROM (B)(6) 2017. THIS PATIENT WAS TRANSPORTED BY EMERGENCY MEDICAL SERVICES (EMS) AMBULANCE FROM HOME TO EMERGENCY ROOM (ER) WITH FAMILY MEMBERS FOR ALTERED MENTAL STATUS EXHIBITING CONFUSION AND AGITATION. PER EMS MEDICS THE PATIENT KEPT SPEAKING TO SOMEONE WHO WAS NOT THERE AND THAT THE PATIENT¿S FAMILY STATED HER AMMONIA LEVEL MAY BE INCREASED BECAUSE THIS HAD HAPPENED IN THE PAST. FURTHERMORE, THE FAMILY STATED THAT RAMBLING AND CONFUSION WAS NOT THE NORMAL FOR THE PATIENT. THE PATIENT DID NOT HAVE HEADACHE, FEVER, OR CHILLS. UPON ER ARRIVAL THE PATIENT ANSWERED QUESTIONS APPROPRIATELY BUT CONTINUING TO SPEAK TO HERSELF. THE PATIENT PRESENTED WITH PROGRESSING AGITATION, CONFUSION AND THRASHING AROUND WITH NO OTHER ASSOCIATED SYMPTOMS. DURING ER EVALUATION PATIENT WAS ADMINISTERED BENZODIAZEPINE IN AN ATTEMPT TO CONTROL AGITATION SUFFICIENTLY TO EXPEDITE CT SCAN EVALUATION, (NEGATIVE WORK UP) AND LUMBAR PUNCTURE (LP) TO RULE OUT MENINGITIS. FOLLOWING LP, PATIENT APPEARED TO IMPROVE BECOMING MORE ALERT, COHERENT, WITH ACCOMPANYING DROWSINESS FROM RECEIVING BENZODIAZEPINE (ATIVAN ONE TIME INTRAVENOUS PUSH (IV )PUSH ) AND HALDOL. ADDITIONALLY THE PATIENT WAS PLACED ON EMPIRIC TRIPLE ANTIBIOTICS DURING ER EVALUATION, VANCOMYCIN, CEFTRIAXONE AND CLINDAMYCIN. VITAL SIGNS ON EVALUATION (B)(6) 2017 INCLUDED: TEMPERATURE: 98.8(ORAL) PULSE:101 (HIGH) RESPIRATORY RATE 18; SYSTOLIC BP:152 (HIGH); DIASTOLIC BP: 112 9 HIGH), MEAN ARTERIAL PRESSURE( MAP )125 MILLIMETERS OF MERCURY (MMHG); PULSE OXIMETRY 95% . FURTHERMORE, A 12 POINT REVIEW OF SYSTEMS WAS PERFORMED AND SHOWED PERTINENT POSITIVES AND NEGATIVES ARE PER HISTORY OF PRESENT ILLNESS, OTHERWISE NEGATIVE. LABORATORY TESTING AND ADDITIONAL DIAGNOSTICS WERE ALSO PERFORMED AS PART OF THE INITIAL AND ONGOING EVALUATION AND ARE NOTED SUBSEQUENTLY IN THIS REPORT. THE PATENT WAS ADMITTED AND DURING HOSPITAL COURSE THE PATIENT RECEIVED BENZODIAZAPINES TO TREAT AND STABILIZE AGITATION, HAD PD THERAPY, AND WAS TREATED WITH NORMAL SALINE TO IMPROVE SODIUM. THE PATIENT RECEIVED HYPERTENSIVE MEDICATIONS TO CONTROL BLOOD PRESSURE (HISTORY OF HYPERTENSION) AND CALCITRIOL WAS DISCONTINUED AND HYPERCALCEMIA WAS CORRECTED. THE PATIENT¿S CONFUSION AND MENTAL STATUS IMPROVED AND WAS DISCHARGED ON (B)(6) 2017 WITH A PLAN TO FOLLOW UP WITH NEPHROLOGIST AT PD CLINIC AND RESUMED PD THERAPY AT HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    417074 LIBERTY CYCLER SYSTEM, PERITONEAL, AUTOMATIC DELIVERY FKX CONCORD MANUFACTURING 00840861100972

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| R