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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 Insufficient Information (4580)
Event Date 01/28/2021
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: a probable temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system and the unspecified serious adverse event(s), characterized by the sequestering of the device. The etiology of the unspecified event(s) is unknown; therefore, causality cannot be established. Limited information precluded a thorough investigation into the unspecified event(s). While advances in technology have significantly reduced the number of serious adverse events incurred during hd therapy, the 2008t hemodialysis system cannot be excluded from having a possible causal or contributory role in the unspecified serious adverse event(s). There is no direct allegation or objective evidence indicating the 2008t hemodialysis system malfunction or deficiency caused the serious adverse event(s). However, given the lack of event(s) specifics (e. G. , hd treatment data, patient demographics, discharge summary, death certificate, esrd death notification), the 2008t hemodialysis system cannot be disassociated from the events.
 
Event Description
A user facility biomedical technician (biomed) contacted fresenius to request onsite testing be performed on a 2008t hemodialysis (hd) machine. Reportedly, the machine had been sequestered following an unspecified event. A fresenius field service technician (fst) was dispatched to the facility to perform functional compliance testing on the system. The machine passed all testing and performed as expected per the manufacturer specifications. Upon follow-up, the biomed stated they were instructed not to discuss the case with anyone, and thus, no event details were provided. Additionally, the fst who performed the testing reported that they were not informed of what had occurred. Subsequent attempts to obtain additional information have thus far proven unsuccessful.
 
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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 Key11388001
MDR Text Key234286322
Report Number2937457-2021-00327
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 03/04/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/26/2021
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 Received02/18/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/02/2018
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: 02/26/2021 Patient Sequence Number: 1
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