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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Cardiac Arrest (1762); Death (1802)
Event Date 10/17/2017
Event Type  Death  
Manufacturer Narrative
The device was not returned to the manufacturer for physical evaluation and the failure mode cannot be confirmed. However, an investigation of the device manufacturing records was conducted by the manufacturer. A serial number search in the ptc complaint system found no complaint issues with the same symptom code within 90 days of the notified date. There were no deviations or non-conformances during the manufacturing process. All device history records (dhr) are reviewed and released according to the dhr review checklist and release procedure. A device is not released if it does not meet requirements or is nonconforming. In addition, the device record review confirmed the labeling, material, and process controls were within specification. A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient expired while dialyzing an requested for a fresenius regional equipment specialist to service the machine. Additional follow-up was made with the clinic manager, who stated expired on (b)(6) 2017 due to cardiac arrest. The patient had been dialyzing for approximately three hours prior to expiration. The patient had been on hemodialysis therapy since (b)(6) 2017. The clinic manager stated the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired. The clinic manager stated after the incident the machine was removed from service for testing and stated no machine repairs were needed and the machine was placed back in service. The clinic manager stated no samples were retained to be returned for evaluation. Medical records were requested.
 
Manufacturer Narrative
Conclusion: although a temporal relationship exists, there is no documentation that suggests a causal relationship between the event of cardiac arrest and subsequent expiration of the patient and the 2008t or any fresenius products. There has be no allegation of device malfunction or deficient product(s) and the association with the event of cardiac arrest and subsequent expiration of the patient. Additionally, the cm stated after the incident the machine was removed from service for testing; no machine repairs were needed, and the machine was placed back in service.
 
Event Description
Information in the complaint file was reviewed by a post market surveillance clinician. It was reported that this end stage renal disease (esrd), hemodialysis (hd) patient presented to the outpatient clinic for hd treatment on (b)(6) 2017; the patient had been dialyzing for approximately three hours (hd treatment details were unknown) when according to the hd clinical manager (cm) the patient experienced a cardiac arrest and expired. All details surrounding this event were unknown. The cm stated the hd machine did not have any issues during set-up and did not alarm at the time the patient expired. Additionally, after the incident the machine was removed from service for testing; no machine repairs were needed, and the machine was placed back in service.
 
Manufacturer Narrative
A supplemental medwatch report will be submitted upon completion of the investigation.
 
Event Description
A biomedical engineer (biomed tech) reported a hemodialysis (hd) patient expired while dialyzing an requested for a fresenius regional equipment specialist to service the machine. Additional follow-up was made with the clinic manager, who stated expired on (b)(6) 2017 due to cardiac arrest. The patient had been dialyzing for approximately three hours prior to expiration. The patient had been on hemodialysis therapy since (b)(6) 2017. The clinic manager stated the machine did not have any issues during set-up and that the machine did not alarm at the time the patient expired. The clinic manager stated after the incident the machine was removed from service for testing and stated no machine repairs were needed and the machine was placed back in service. The clinic manager stated no samples were retained to be returned for evaluation. Medical records were requested.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key7007234
MDR Text Key105966578
Report Number2937457-2017-01151
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
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 11/20/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/07/2017
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190713
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 Received11/16/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/10/2012
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: 11/07/2017 Patient Sequence Number: 1
Treatment
ATORVASTATIN; CALCIUM CARBONATE; GABAPENTIN; HUMALOG; JANUVIA; METOLAZONE; RENAVITE; RENVELA; TANTOPRAZOLE
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