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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 Death (1802); Respiratory Distress (2045); Diaphoresis (2452); Sudden Cardiac Death (2510)
Event Date 09/06/2017
Event Type  Death  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The unit was pulled from service for evaluation by the facility biomedical engineer (biomed) following the event. The machine did not require any repairs and was confirmed to be operating properly. The unit has been returned to service at the user facility without a recurrence of the event as reported. 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 during the manufacturing process which could be associated with 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. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted. A clinical investigation was performed to identify a causal relationship between the patient's hd treatment and the patient passing away. Currently, there are no allegations against any fresenius products involved in this event. There is no documentation of any defects with the fresenius products and there is no available death certificate for review. Based on the provided information, it cannot be determined if there is a causal relationship between the patient passing away and the use of the fresenius 2008t machine. A temporal association between the adverse event and the patient¿s hd treatment remains. Should additional new information be made available this clinical investigation will be reevaluated.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity. The uf/importer number was listed as (b)(4) but is marked as an invalid number.
 
Event Description
A healthcare professional at a user facility reported that a patient passed away following treatment on a fresenius 2008t hemodialysis (hd) machine. Prior to treatment, the patient had a recorded blood pressure of 125/78 and a pulse of 84 beats per minute. The patient¿s respiratory measurement was 18. The patient initiated treatment via a right tunneled jugular catheter without complaint at about 15:36. The patient received dialysate via a central feed. Thirty minutes into treatment, the patient was reported to be resting comfortably. At about 16:27, the patient was administered doses of mircera (50mcg, ivp), venofer (100mg, ivp), and hectorol (2. 0mcg, ivp). Approximately three minutes later, the patient reported that they were not feeling well and were unable to breathe. The patient became pale, diaphoretic and unresponsive. Treatment was discontinued. The user facility called 911 and the patient coded. The automated external defibrillator detected no rhythm and three rounds of cpr were performed. The ambulance arrived and the patient was transported to the hospital emergency room. The patient subsequently passed away. Upon follow up with the user facility, it was noted that there were no malfunctions or alarms during the patient¿s hd treatment. The cause of the patient¿s death was unknown and the patient¿s family declined an autopsy. The 2008t hd machine was removed from service for an evaluation by the on-site biomedical technician (biomed). The machine passed all functional tests and no repairs were required. The machine was returned to service. No malfunction of any fresenius products in use during the hd treatment was alleged, observed, or identified prior to, during, or following the event. The dialyzer is not available to be returned to the manufacturer for evaluation as it was discarded by the user facility. No samples of the acid/bicarb in use during the treatment are available for analysis.
 
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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
4040 nelson avenue
concord CA 94520
Manufacturer Contact
thomas c. johnson
920 winter st.
waltham, MA 02451
7816999499
MDR Report Key6950617
MDR Text Key105951517
Report Number2937457-2017-01031
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
Type of Report Initial,Followup
Report Date 11/16/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/15/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/16/2015
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: 10/15/2017 Patient Sequence Number: 1
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