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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Fluid Leak (1250)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/12/2018
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
It was reported a blood leak that occurred during a patient¿s hemodialysis (hd) treatment. Blood was backing up due to a drip chamber adjustment problem. The patient¿s estimated blood loss (ebl) was unknown. It was reported that there was no patient illness or injury as a result of this event. On-site repairs were performed by a fresenius regional equipment specialist (res) and the machine was subsequently returned to service. Additional patient and event information was requested, but was not provided.
 
Manufacturer Narrative
Plant investigation: the level detector was returned to the manufacturer. The level detector module was returned with unknown substance and corrosion around the front plate, housing, and optical sensor. The unknown substance can also be found in the venous line and filter. The ground wire from the level detector relay board is disconnected from the lp450 board, due to a broken ground pin on tp3 of the lp450 board. With the returned level detector connected, the test machine functioned properly in dialysis. The level detector was able to create an air detector alarm and the line clamp closed when the drip chamber was removed. After the drip chamber was reinserted into the level detector module, the test machine was able to clear the air detector alarm after pressing the reset key and the line clamp opened. The line occlusion clamp was able to withstand the pressure of 30 psi. There were no bubbles flow from the other side of the tubing when submerge in water. The occlusion clamp functioned properly. The blood pump speed dropped from 600 ml/min to 150 ml/min when the (up) position of the level adjust button is pressed. The pven is opened to atmosphere and the occlusion clamp closed. When the down position of the level adjust button was pressed the occlusion clamp was open and air was expelled through the venous pressure port. An air detector alarm occurred with the level detector was unplugged from the test machine. A review of the device manufacturing records was conducted by the manufacturer. There were no deviations or non-conformances during the manufacturing process. In addition, a device history record (dhr) review was performed and verified that the results of the in-progress and final quality control (qc) testing met all requirements. Upon completion of the evaluation, there were no malfunctions that could have caused or contributed to the reported event. The level detector performed as designed and an associated cause could not be determined.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key8179517
MDR Text Key130911576
Report Number2937457-2018-03702
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 company representative,user f
Type of Report Initial,Followup,Followup
Report Date 03/13/2019
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/27/2018
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received03/11/2019
Is This a Reprocessed and Reused Single-Use Device? No

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