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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 Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Hypovolemia (2243); Loss of consciousness (2418)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the unknown hd system and the adverse events of hypovolemia, hypotension, loss of consciousness, and dyspnea. Per the patient, the serious adverse events occurred due to removing to much fluid. Given the limited information provided, the patient likely experienced an episode of intradialytic hypotension due to hypovolemia. Hypotension is the most prevalent complication associated with hd and occurs in approximately 25% of all treatments. Very often, the cause of the hypotension is multifactorial. Based on the information available, the unknown 2008 system can be disassociated from the event(s). There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction caused or contributed to 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.
 
Event Description
Fresenius became aware (via a customer experience survey) this unknown patient with end stage renal disease (esrd) previously on hemodialysis (hd) for renal replacement therapy (rrt) experienced an episode of intradialytic hypotension (systolic blood pressure 50¿s). The patient reportedly ¿passed out¿ (loss of consciousness) after too much fluid was removed (hypovolemia) and was found ¿gasping for breath¿ (dyspnea). Knowledge of the serious adverse events was obtained from a customer experience survey, in which the patient chose to remain anonymous. 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key14802542
MDR Text Key295066089
Report Number0002937457-2022-01031
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 06/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/24/2022
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: 06/24/2022 Patient Sequence Number: 1
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