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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 01/19/2021
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship does not exist between hd therapy utilizing the 2008t hemodialysis system, and the serious adverse event of death. Per the hospitals doh, the patient was not undergoing hd therapy when he/she expired. The definitive cause of the patients death is unknown; therefore, causality cannot be firmly established. The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. Additionally, adults with esrd have mortality rates up to 30-fold higher than the general population. Based on the limited information available, the 2008t hemodialysis system can be disassociated from the events. There is no allegation or objective evidence indicating that a fresenius product or device may have caused or contributed to the patients expiration. Plant investigation: no parts were returned to the manufacturer for physical evaluation. However, a fresenius field service technician (fst) performed an onsite evaluation of the machine. No non-conformances were noted during functional compliance and ultrafiltration testing; no problems were found with the system. 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. Upon completion of the fst's evaluation, no problems were detected and the 2008t hd system was returned to service. The investigation into the cause of the reported problem was not able to be confirmed.
 
Event Description
A biomedical technician (bmt) contacted fresenius technical support to request the onsite evaluation of a 2008t hemodialysis (hd) machine. The bmt reported that an hd patient experienced a serious adverse event following hd therapy (timeline not provided) on (b)(6) 2021. During follow-up, the director of hemodialysis (doh) reported the patient was not actively dialyzing when they expired (specifics not provided). Additionally, it was confirmed the 2008t hd system was sequestered following the events and was serviced by a fresenius representative. The doh stated no non-conformances were noted during functional compliance and ultrafiltration testing, and the 2008t hd system was returned to service. The functional compliance testing was performed per hospital policy, and not due to suspicion of causality. The doh refused to provide any additional information.
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
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 Key11324181
MDR Text Key231695373
Report Number2937457-2021-00251
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 02/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received01/20/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/10/2019
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: 02/12/2021 Patient Sequence Number: 1
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