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Catalog Number 190610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 07/24/2018
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
Event Description
A user facility clinic manager reported a fresenius 2008k2 hemodialysis machine that sounded a false blood leak alarm due to a patient having methyl blue in their bloodstream on (b)(6) 2018. The patient could not be dialyzed, and was flown to a hospital, where they expired within 48 hours of (b)(6) 2018. The machine passed functional checks and returned to service without issue. Additional patient and machine information was requested, but was not provided.
Manufacturer Narrative
Patient information, added patient identifier, date of birth, sex, and weight. Clinical investigation. Added device manufacture date. Corrections: changed averse event to yes, changed product problem to no. Changed death to yes, hospitalization to yes. Changed date of event to (b)(6) 2018. Updated catalog number, serial number, and udi the plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
Manufacturer Narrative
Plant investigation: the machine was inspected by fresenius biomedical technician, and it passed all functional tests and returned to service without issue. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.
Manufacturer Narrative
Additional information: clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 fresenius dialysis machine and an inability to initiate hemodialysis therapy due to a blood leak alarm resulting in delay of care. Causality for the false blood leak alarm was attributed to the patient receiving methylene blue during surgery due to right ventricular failure. It is likely the methylene blue caused a discoloration of the spent dialysate which triggered a false blood leak alarm; thus preventing the blood pump from engaging unless overridden. The blood leak detector functions by monitoring for discoloration in spent dialysate as it passes through a glass cuvette. When discolorations are noted, the blood leak detector will stop the blood pump. This is an intended design and may result in false blood leak alarms. It should be noted, no harm will result from the false blood leak alarm. Harms will be consequences of interruption of hd therapy while treating acute kidney injury patients and not as a result of device malfunction. It should be noted the patient expired approximately 48 hours after transfer, however the details surrounding the patient¿s death are unavailable. The patient¿s comorbid conditions prior to transfer included: endocarditis, renal failure, pulmonary hypertension, acute respiratory distress syndrome and metabolic acidosis. The patient was listed as critically ill prior to transfer to a tertiary care facility. Based on the information available, there is no allegation or evidence of an actual blood leak, machine malfunction or of the machine failing to perform as expected in relation to the event(s). Additionally there is no documentation or evidence the 2008k2 dialysis machine caused or contributed to a serious adverse event.
Event Description
Additional information - a patient was hospitalized on (b)(6) 2018 for complaints of fever, malaise, body aches, jaundice, nausea, vomiting, and weight loss for several days. The patient¿s medical history includes intravenous (iv) drug abuse and endocarditis, requiring an aortic valve (av) and mitral valve (mv) replacement in (b)(6) 2018. The patient had a recent relapse (details unknown). The patient vitals on admission were: temperature
103. 8, pulse
120+, blood pressure
systolic - 90/diastolic - unknown, oxygen saturation
92-97% on room air. The patient underwent abdominal/pelvis, head and chest computed tomography scans which showed bilateral lung apices, splenomegaly, and peri-portal edema within the liver. Blood cultures were positive for staphylococcus mitis, and the patient was treated with iv vancomycin and ceftriaxone. The patient continued to be severely anemic with worsening shortness of breath. The patient was placed on bipap and given lasix with improvement. The patient underwent a right heart catheterization, which showed elevated filling pressures, severe mitral regurgitation, and cardiogenic shock. A surgical replacement of the av/mv was decided. During surgery the patient required significant amounts of inotropic support for right ventricular failure; including iv epinephrine, vasopressin boluses and methylene blue (mb). Following surgery the patient was transferred to the cardiovascular icu and their condition worsened overnight requiring additional ventilator support, sedation and paralyzation. The patient was acidotic and receiving both iv and bolus bicarbonate. The patient required v-pacing for complete heart block and hemodialysis (hd) for marginal urine output and a rising creatinine level. An hd catheter (not a fresenius product) was surgically placed. While attempting to initiate hd, the 2008k2 dialysis machine incurred a ¿blood leak detected¿ alarm which could not be resolved. The medical staff surmised the mb given during surgery caused the false blood leak alarm to occur. The nephrologist decided to place the patient on continuous veno-venous hemofiltration, however there is no treatment data available for review. The patient was in hepato-renal failure with elevated liver function tests, and was given fresh frozen plasma, packed red blood cells and cryoprecipitate. The patient continued to require epinephrine, dopamine and norepinephrine for blood pressure support, and the decision was made to medical flight the patient to another hospital. Discharge diagnoses included endocarditis, renal failure, pulmonary hypertension, ards and metabolic acidosis. The patient was subsequently transferred to another hospital on (b)(6) 2018, where they expired approximately 48 hours later.
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Brand Name2008K2 MACHINE
Manufacturer (Section D)
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
MDR Report Key7864628
MDR Text Key119829248
Report Number2937457-2018-02670
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup,Followup,Followup,Followup
Report Date 10/11/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/11/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/13/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/28/2010
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 09/11/2018 Patient Sequence Number: 1