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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING UNKNOWN-2008 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING UNKNOWN-2008 DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008 MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system, and the adverse event of cardiac arrest. The definitive cause of the patient¿s adverse event(s) is unknown; therefore, causality cannot firmly be established. Given the patient¿s identity remains unknown, an inability to obtain additional information precluded a more comprehensive investigation. Based on the totality of the information available, the 2008 hemodialysis system cannot be excluded from having a possible causal and/or contributory role in the serious adverse events. At this time, there is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred. However, given the patient was reportedly undergoing hd therapy when the events began and the lack of additional information (e. G. , treatment record, hospital records, timeline, patient demographics); his clinical investigation cannot disassociate the device from the serious adverse events. Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained. As a serial number could not be determined, device history and manufacturing records could not be reviewed. 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.  .
 
Event Description
Fresenius became aware (via a customer experience survey) that this unknown patient with end stage renal disease (esrd) previously on hemodialysis (hd) for renal replacement therapy (rrt) ¿coded¿ (cardiac arrest) during treatment. No additional information was provided during intake. Knowledge of the cardiac arrest was obtained from a customer experience survey in which the patient was not named. As such, written or telephonic follow-up was not possible.
 
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Brand NameUNKNOWN-2008
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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13957341
MDR Text Key288371815
Report Number2937457-2022-00518
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 03/30/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN- 2008 MACHINE
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/02/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 03/30/2022 Patient Sequence Number: 1
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