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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
Catalog Number UNKNOWN-2008K MACHINE
Device Problem Inadequate Ultra Filtration (1656)
Patient Problem Loss of consciousness (2418)
Event Date 08/23/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
A hemodialysis (hd) patient reported via social media that they experienced difficulties with cramping, blacking out at the start of treatment. At the end of treatment, the patient reported that their weight was lower than the targeted weight. The patient reported that a biomed technician figured out that rinse should not be added to the target amount. It is unknown whether the patient was able to complete treatment on the same machine, and the patient experienced fluctuations in weight, cramping and loss of consciousness as a result of this incident. No additional information was provided or was available.
 
Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). A records review and an investigation of the device manufacturing records could not be performed, as no serial number was provided. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device. Clinical investigation: while a temporal relationship between hemodialysis (hd) treatment with the fresenius 2008k machine and the patient¿s symptoms of cramping and loss of consciousness exists, there is no allegation or documentation that indicates a fresenius product deficiency or malfunction was associated with the patient¿s adverse event. It is conceivable the patient¿s cramping and loss of consciousness was related to adding in the saline rinse to the patient¿s target fluid removal goal which may have resulted in excessive ultrafiltration.
 
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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 Key7872373
MDR Text Key120117761
Report Number2937457-2018-02708
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
Type of Report Initial,Followup
Report Date 09/17/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
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 Received09/13/2018
Is This a Reprocessed and Reused Single-Use Device? No

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