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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 Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemolysis (1886)
Event Date 06/19/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a temporal relationship exists between the hemodialysis treatments performed on (b)(6) 2019 using the 2008 t hemodialysis machine, fresenius bloodlines, fresenius dialyzers, granuflo acid, naturalyte 4000 bicarbonate, fresenius clic blood chamber and the patient¿s hemolysis event requiring hospital admission for blood transfusion. The clinic investigation has not successfully identified the source of the hemolysis. There is no objective evidence of any user error, non-compliance to standard operating procedure, chemical/toxic exposures, or any thermal/mechanical causes. The manufacturer¿s product analysis is pending at the time of this clinical investigation. Therefore, any concomitant fresenius products utilized cannot be excluded as a possible causal or contributory factor in the event. There have been no reported defects with any fresenius products used in relation to this event. There have not been any new reports of any additional hemolysis cases associated with use of fresenius products. The granuflo mix and bicarbonate mix tested had a normal specific gravity according to documentation on clinic logs. Moreover, it was reported there were no conductivity alarms on the 2008 t machines. Electrolyte panels of the final dialysate were also within normal limits. The patient sodium levels were normal. It appears unlikely an osmolar insult from the acid or bicarbonate occurred. The patients were not using the same size or lot of optiflux dialyzers which suggests the dialyzers did not cause the hemolysis event due to the degree of variability. There were no reported blood leaks or defects with any of the optiflux dialyzers used. All 2008 t machines passed pre-treatment and post -event functionality testing. There were no unexpected machine alarms in relation to the event. The cause of the hemolysis cannot be determined. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
An area technical operations manager (atom) reported that a hemodialysis patient experienced hemolysis event. Upon follow up, the hemolysis event appears to have occurred between (b)(6) 2019. The patient¿s pre-hemodialysis treatment labs were drawn on (b)(6) 2019 without any reported issues with the lab specimen. On (b)(6) 2019, the clinic manager reviewed the lab results which were drawn post hemodialysis treatment and noticed the patient had a drop in their baseline hemoglobin from 10. 6 to 8. 4. The patient was admitted into the hospital on (b)(6) 2019 with a hemoglobin of 6. 7 and required a blood transfusion. The patient was discharged on (b)(6) 2019. Further details regarding the patient¿s hospitalization are currently unknown. Reportedly, the patient continues to receive hemodialysis treatments. The patient was reported dialyzing with a fresenius 2008t hemodialysis machine, fresenius bloodlines, fresenius dialyzers, fresenius granuflo acid (2551) 2. 0 potassium/2. 5 calcium, fresenius naturalyte 4000 bicarbonate, fresenius clic blood chamber and fresenius normal saline. It was reported there were no visual defects or anything unexpected with any of the fresenius products used, as well as no machine alarms, clotting events and/or dialyzer leaks in relation to the hemolysis event. It was reported there was nothing unusual in any of the hemodialysis treatments. There were no visible signs of hemolysis during any treatment such as, translucent/cherry colored blood (which is typical with hemolysis in hemodialysis) or any patient symptoms. The patient completed all their hemodialysis treatments during the timeframe without any adverse effect. Currently, the cause of the hemolysis event is unknown. The actual and companion samples of the fresenius products used between (b)(6) 2019 have been sent to the manufacturer for further investigation.
 
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Brand Name2008T MACHINE
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
Manufacturer (Section D)
CONCORD MANUFACTURING
4040 nelson avenue
concord CA 94520
Manufacturer (Section G)
CONCORD MANUFACTURING
director, quality systems
4040 nelson avenue
concord CA 94520
Manufacturer Contact
matthew amaral
920 winter st.
waltham, MA 02451
7816999758
MDR Report Key8808203
MDR Text Key151616093
Report Number2937457-2019-02222
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K093902
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup,Followup
Report Date 10/21/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/19/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN-2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received09/26/2019
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: 07/19/2019 Patient Sequence Number: 1
Treatment
FRESENIUS BLOODLINES; FRESENIUS CLIC BLOOD CHAMBER; FRESENIUS DIALYZER; FRESENIUS GRANUFLO ACID; FRESENIUS NATURALYTE 4000 BICARBONATE; FRESENIUS NORMAL SALINE
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