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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.
 
Manufacturer Narrative
Additional information: h3 plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).The fst reported that the machine passed all functional checks.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.The fresenius fst was unable to identify any problems with the hemodialysis (hd) machine during testing.The 2008t hd machine performed as designed and no problems were detected.
 
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 Name
2008T HD SYS. CDX W/BIBAG BLUE STAR
Type of Device
DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
MDR Report Key11388001
MDR Text Key234286322
Report Number2937457-2021-00327
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
Combination Product (y/n)N
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
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 Health Professional
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Device AgeMO
Date Manufacturer Received02/18/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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