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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 02/14/2020
Event Type  Injury  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. However, an on-site evaluation was performed by a fresenius field service technician (fst). To resolve the reported alarm issue, the fst replaced the air detector sensors. 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. The investigation into the cause of the reported problem was able to confirm the reported failure mode. However, the reported patient event was not attributed to the use of the fresenius 2008t machine. Clinical investigation: there is a temporal relationship between hd therapy utilizing the 2008t machine and the patient event of cardiac arrest. However, there is no documentation in the complaint file to show a causal relationship between the event and use of the 2008t machine. Additionally, there is no allegation of a machine malfunction or deficiency reported for the event. It was confirmed that there were no machine issues including the air detector alarm during this patient¿s treatment. The patient was hospitalized and suffered multiple cardiac arrest events and was not expected to survive. End stage renal disease (esrd) patients are at increased risk for mortality with cardiovascular disease as the major cause of death. Sudden cardiac death accounts for the majority of those deaths. Based on the available information pertaining to the patient¿s poor prognosis and no allegation of a malfunction or deficiency, the fresenius 2008t machine can be excluded as the cause of the patient¿s cardiac arrest event.
 
Event Description
A fresenius field service technician (fst) was called onsite by a user facility to evaluate a 2008t hemodialysis (hd) machine that experienced an air detector alarm. It was later reported that a patient coded during their treatment on the aforementioned machine. Additional information was obtained through follow up with the charge nurse. The patient that coded, a fresenius home hd patient, was a hospital patient at the time of the event. Initially the patient was transported to the emergency room (er) for not feeling well (date unknown). During transport, the patient went into cardiac arrest. The patient was resuscitated; however, suffered a second event of cardiac arrest in the er. The patient was once again resuscitated. The patient reportedly had a history of non-compliance with their dialysis treatments. As a result, the patient presented to the hospital with elevated potassium levels (unknown value). The patient's prognosis was poor. As part of the patient¿s orders, hemodialysis was initiated on 14/feb/2020 on the 2008t machine. Approximately 28 minutes into the dialysis treatment the patient suffered another cardiac arrest event. The patient was again resuscitated. It was not confirmed if the treatment was completed after the event. The patient expired a few days later (date not provided). Per the charge nurse, the cardiac arrest event was unrelated to the patient¿s hd therapy or the 2008t machine. There were no issues with the machine during the patient¿s treatment. The reported air detector alarm issue did not occur during this patient¿s treatment. The patient¿s cardiac history prior to this hospitalization was unknown; however, the patient was not expected to survive. The air detector sensors were replaced on the 2008t machine to address the alarm issue. The machine passed all functional checks after the repair was completed and was returned to service.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key9815127
MDR Text Key182910444
Report Number2937457-2020-00462
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup,Followup
Report Date 05/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/11/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received05/07/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/14/2016
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: 03/11/2020 Patient Sequence Number: 1
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