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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
Catalog Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Seizures (2063); Loss of consciousness (2418)
Event Date 10/10/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a clinical investigation was performed. A temporal relationship exists between hd therapy utilizing the 2008t hemodialysis machine and the patient¿s loss of consciousness, which warranted hospitalization. However, the 2008t hemodialysis machine can be disassociated from these events, as there is no allegation or objective evidence indicating a fresenius product deficiency or malfunction was associated with these events. The patient experienced a seizure during hd therapy on (b)(6) 2019, which led to a loss of consciousness. Per the cm, the events were unrelated to the utilization or functionality of the 2008t hemodialysis machine. The cm reported causality is attributed to a newly diagnosed seizure disorder. Additionally, the 2008t hemodialysis machine passed all functional compliance testing post event and was found to be operating within manufacturer specifications. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An fst (field service technician) was called onsite by a user facility to repair a 2008t machine with a reported evaluation of functional checks for 2008t. The 2008t hemodialysis machine was found to be functioning as intended, per the manufacturer¿s specifications. Following the testing, the 2008t hemodialysis machine was returned to service. The fst reported that the patient lost consciousness and was transferred to a hospital. Upon follow up the clinic¿s manager (cm) reported the patient experienced a seizure (specifics not provided) during dialysis and lost consciousness (specifics not provided). The hd treatment was discontinued, the patient¿s blood was returned and emergency medical services (ems) was called. The patient regained consciousness (specifics not provided) shortly after discontinuing the hd treatment, and ems transported the patient to the hospital for evaluation. At the hospital, the patient was diagnosed with a newly discovered seizure disorder (specifics not provided), and the patient was placed on medication (drug, dose, frequency not provided). The patient was discharged home (date not provided) in stable condition and continues to undergo hd therapy without issue. The cm reported the patient recovered from the event and has not suffered another seizure since. The discharge summary, treatment data, patient demographics, past medical history and medication list were requested; however, the request was declined. The cm stated the patient¿s loss of consciousness was unrelated to hd therapy or any fresenius product(s) or device(s), despite it occurring during hd therapy.
 
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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
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 Key9214119
MDR Text Key163053456
Report Number2937457-2019-03216
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/21/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/23/2018
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: 10/21/2019 Patient Sequence Number: 1
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