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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Apnea (1720); Cardiac Arrest (1762)
Event Date 11/27/2018
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis sys olc/diasafe pls and the serious adverse event(s) of loss of consciousness and subsequent death. The cm stated the cause of death is unknown; however, the patient had a past medical history including arteriosclerosis and hypertension. Cardiovascular morbidity and mortality are known to be significantly higher in esrd patients, when compared to the general population. Based on the information available the 2008k2 hemodialysis sys olc/diasafe pls can be disassociated from the event, as there is no evidence or indication a fresenius product(s) or device(s) caused or contributed to a serious adverse event. Additionally, there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event. Furthermore, the 2008k2 hemodialysis sys olc/diasafe pls passed all function compliance testing following the event. Plant investigation: no parts were returned to the manufacturer for physical evaluation. An on-site evaluation was performed by a fresenius regional equipment specialist (res), who confirmed that the machine passed all functional testing without issues. 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.
 
Event Description
On (b)(6) 2018, a user facility biomedical technician (bmt) called fresenius technical support regarding this (b)(6) male patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) for approximately 3 years coding during hd therapy on (b)(6) 2018. The patient reportedly expired later that day (specifics not provided). The patient¿s past medical history includes arteriosclerosis and hypertension. During follow-up on (b)(4) 2018, the user facility clinical manager (cm) reported the patient complained of itching (specifics not provided) at the initiation of hd therapy on (b)(6) 2018. The cm reported this was a common occurrence, and hd therapy began as ordered. The patient coded (pulseless/breathless) 15 minutes into treatment (specifics not provided), and the patient¿s blood was returned (specifics not provided). The patient had a do not resuscitate (dnr) order, as such cardiopulmonary resuscitative (cpr) measures were not performed. The patient subsequently expired later that day (specifics/timeline not provided). The cause of death is currently unknown. Additional information was requested during the call; however, no further information was provided. A regional equipment specialist (res) performed functional compliance testing on the suspect 2008k2 on 12/06/2018. The res¿s service record states the 2008k2 passed all testing with no alarm failures. The machine was found to be in proper working order and within manufacturer specifications.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key8165246
MDR Text Key130365905
Report Number2937457-2018-03668
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
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
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/14/2018
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190610
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 Received11/27/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/11/2009
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: 12/14/2018 Patient Sequence Number: 1
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