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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008T MACHINE
Device Problem Fluid Leak (1250)
Patient Problems Vomiting (2144); Loss of consciousness (2418)
Event Date 03/04/2022
Event Type  malfunction  
Event Description
A user facility area technology operations manager (atom) reported a blood leak occurred between the combiset bloodlines near the arterial transducer connection to the thicker tubing for blood pump. The leak was visually observed and a separated connection caused a leak from the pump wheel door. The leak was noticed approximately 1 hour 49 minutes into treatment. There were no loose connections detected at the time and connections were tested prior to treatment. There was no damage or defect seen on the combiset. When the leak was noticed, the treatment was discontinued. The patient¿s estimated blood loss (ebl) was approximately 700 ml. The patient experienced a loss of consciousness after blood loss, however the patient regained consciousness and then vomited once after the rapid response. A normal saline bolus of 150 ml was administered per standing order. The patient was not admitted to the hospital and returned home that day without medical intervention. The patient was on a fresenius 2008t with bibag machine and using a fresenius dialyzer. There were no changes or a disruption in pressure that could have caused the issue. Additionally, the sample has been discarded and is not available to be returned to the manufacturer for physical evaluation.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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Brand Name2008T MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13804299
MDR Text Key287409926
Report Number2937457-2022-00408
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/08/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/18/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received04/01/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

Patient Treatment Data
Date Received: 03/18/2022 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES.; FRESENIUS DIALYZER.
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