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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 2008K MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Loss of consciousness (2418)
Event Date 08/15/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
During follow up for a separate event, it was reported the patient was hospitalized for ¿passing out¿, possibly due to electrolyte imbalance. Upon follow up, the pdrn reported that the patient was already hospitalized (date unknown) for a separate issue unrelated to dialysis. The patient was permanently transitioned to hemodialysis (hd) as a result of that issue. During that hospitalization, the patient passed out during hemodialysis treatment (unknown time into treatment) on the fresenius 2008k machine. Patient vitals and treatment information are unknown. The event could have been caused by an electrolyte imbalance (unspecified) as initially reported. It is unknown what treatment the patient received or if the hd treatment was completed. No additional information was obtained.
 
Manufacturer Narrative
There is a temporal relationship between the patient event of passing out and hd treatment on the 2008k machine. There is no documentation to show a causal relationship between the adverse event and the 2008k machine. Additionally, there are no reported allegations of malfunction or deficiency against the 2008k machine. Based on the available information a cause of the reported adverse event cannot be determined.
 
Manufacturer Narrative
The device was not returned. The serial number is unknown. A search of the devices history could not be performed.
 
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Brand Name2008K MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7841548
MDR Text Key119030218
Report Number2937457-2018-02563
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K994267 
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,health professional
Type of Report Initial,Followup,Followup
Report Date 09/18/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/04/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number2008K MACHINE
Device Catalogue NumberUNKNOWN- 2008K MACHINE
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/14/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 09/04/2018 Patient Sequence Number: 1
Treatment
DELFLEX PD SOLUTION; LIBERTY CYCLER SET; DELFLEX PD SOLUTION; LIBERTY CYCLER SET
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