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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM W/BIBAG DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190766
Device Problems Air Leak (1008); No Audible Alarm (1019)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/15/2018
Event Type  malfunction  
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation. There was no on-site evaluation of the unit performed by a fresenius regional equipment specialist (res). The user facility biomedical technician (biomed) evaluated the machine and confirmed it was functioning properly. 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 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.
 
Manufacturer Narrative
No parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res). The plant investigation is in process. A supplemental medwatch report will be submitted upon completion of this activity.
 
Event Description
A user facility nurse reported that the venous chamber would not hold prime at the start of a patient¿s hemodialysis (hd) treatment, allowing air to enter the bloodlines. Prior to the start of hd treatment, the fluid in the venous chamber was dropping, so the nurse filled the lines with saline during priming. When the patient¿s blood was in the venous chamber, it was reported that the blood dropped so low, air had entered the bloodlines. There was no machine alarm. The nurse removed the venous bloodline section and replaced it with another venous line from the same lot number. The nurse stated that the same thing happened where the blood dropped below level, allowing air to enter in the bloodline. The patient¿s blood was not returned from both sets of venous bloodlines and the total estimated blood loss (ebl) was noted as more than 200ml. The patient completed treatment with a set-up of new supplies on a different machine. No patient adverse effects or injuries were experienced, and no medical intervention was required. The patient was able to complete treatment without any further interruptions or complications. The patient¿s hemoglobin was tested after treatment as the patient had a low hemoglobin level prior to the start of treatment, however, no actions were taken regarding the blood loss. The patient continues regularly scheduled hd treatments without issue. The machine was removed from service following the event. The user facility biomedical engineer (biomed) evaluated the machine and confirmed it was functioning properly. The machine was still sequestered pending clinical approval prior to putting back into service. There was no reported defect or crack with either set of bloodlines used. The bloodline device was stated to be available to be returned to the manufacturer for evaluation.
 
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Brand Name2008T HEMODIALYSIS SYSTEM W/BIBAG
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
MDR Report Key7240549
MDR Text Key280777306
Report Number2937457-2018-00356
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 02/28/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/05/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number190766
Was Device Available for Evaluation? No
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/21/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 02/05/2018 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES
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