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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190713
Device Problem Fluid Leak (1250)
Patient Problems Low Blood Pressure/ Hypotension (1914); Dizziness (2194); Malaise (2359); Blood Loss (2597)
Event Date 06/06/2018
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported that a 2008t machine's blue dialyzer tubing split. The machine alarmed "blood leak". The patient lost approximately 200ml of blood and felt unwell, dizzy and had low blood pressure. Saline solution was administered and the patient was moved to another machine to complete treatment.
 
Manufacturer Narrative
A clinical investigation was performed to identify a causal relationship between the hemodialysis (hd) treatment and the adverse event. Based on the provided information there is a possible causal relationship between the hd treatment on the fresenius 2008t machine and patient not feeling well, dizziness and hypotension resulting in administration of saline to the patient. The patient¿s symptoms could be a result of the approximately 200ml blood loss which resulted from the internal fluid leak in the machine. However, these are also common recurrent symptoms experienced during hd therapy. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
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 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 investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7612060
MDR Text Key111429305
Report Number2937457-2018-01718
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup,Followup
Report Date 07/09/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190713
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/18/2018 Patient Sequence Number: 1
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