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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
Model Number 190766
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Insufficient Information (4580)
Event Date 02/03/2022
Event Type  Death  
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between hemodialysis therapy utilizing the fresenius 2008t machine and the patient event of coding with subsequent death. However, there is no documentation in the complaint file to show a causal relationship between use of the machine and the patient¿s adverse event. Although a cause of death had not been documented, the patient was described as frail, weak, and in declining health with suggestions from medical personnel to transition to hospice. The incidence of sudden cardiac death in hd patients is more than 50 times greater than in the general population and attributes for about a quarter of the total mortality of hd patients. The machine functional checks all passed, and no issues were encountered with the machine during treatment. Based on the available information and no allegation or evidence of a malfunction or deficiency, the fresenius 2008t machine can be excluded as the cause of the patient coding and subsequent death. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A biomedical technician (biomed) at a user facility reported that a hemodialysis (hd) patient coded on machine during treatment. The patient was sent to the hospital and passed away. There were no diagnostic messages or audible alarms. There was no reported problems with the treatment. Upon follow-up, the hd charge nurse reported this hd patient arrived for a regularly scheduled hd treatment. It was the patient¿s first hd treatment returning to the clinic since being discharged from the hospital for weakness (dates unknown). The patient was described as weak, frail, and in declining health. The doctors had been trying to get the patient¿s spouse to place the patient in hospice. The patient started a four-hour treatment in stable condition. The patient was noted as being very sleepy although able to be aroused. The patient¿s blood pressure (bp) was erratic (no values provided) during the treatment; however, this was normal for this patient. During the treatment, the patient was administered a normal saline fluid bolus (volume not provided) for low bp (value unknown). With approximately 28 minutes remaining in the four-hour treatment, the patient coded. The treatment was discontinued and 911 was called. Resuscitative efforts were performed. Prior to transport by emergency medical services (ems), the patient did have a pulse and blood pressure reading of 146/87; however, was not alert. The patient was transported at approximately 4:40pm to the hospital. The patient subsequently expired at the hospital at approximately 5:45pm. The cause of death has not been documented with the clinic. No further information was available as the patient¿s records have been closed out of the system. The nurse stated there were no issues with the 2008t machine or any dialysis products during the patient¿s treatment. The machine passed all functional checks as well as uf pump calibration and had since been returned to service.
 
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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
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 Key13535643
MDR Text Key285628936
Report Number2937457-2022-00249
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K121341
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/24/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/15/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number190766
Device Catalogue Number190766
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received02/22/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured05/19/2016
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: 02/15/2022 Patient Sequence Number: 1
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