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U.S. Department of Health and Human Services

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

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CONCORD MANUFACTURING 2008K MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008K MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Weakness (2145); Malaise (2359); Neck Pain (2433); Shaking/Tremors (2515)
Event Date 01/01/2020
Event Type  Injury  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity. Clinical investigation: there were no recorded issues with any fresenius device/ product in relation to the event. No further information is currently available. Weakness and fatigue are not uncommon symptoms experienced by patients with renal failure and long-term dialysis patients; estimates affecting from 42% to 89% of patients. This is often due to many potential etiologies including but not limited to, physiologic aspects of renal failure, concomitant comorbid conditions, and side effects from the hd treatment itself. Moreover, it is not uncommon for patients to change dialysis modality to improve these symptoms and quality of life. Based on the available information, there is no reported allegation objective evidence that a fresenius device or product issue caused or contributed to a serious patient harm or injury.
 
Event Description
A hemodialysis (hd) patient stated at their doctor's suggestion, to start peritoneal dialysis (pd) dialysis a couple of weeks ago (exact date unspecified). The patient reported they loved that they did not have to get stuck with needles anymore. The patient also stated that they suffer from degenerative disc disease (ddd) and spinal stenosis. The patient stated sitting in a chair for 3+ hours was very hard on their neck and back. Additionally, i the patient reported they often felt sick, weak and shaky after a treatment. It has been less than 2 weeks since the patient started home dialysis and they feel much better already. Upon follow-up, the patient stated that they did not know how the equipment malfunctioning would cause them to feel "bad". The patient stated that they think that the treatment (removing blood and returning it after cleaning it) is an unnatural procedure and is hard on a person's body. The patient had their fluid intake at optimum levels and their lab work show levels that were in good range. The patient believed that because they were losing weight, they may have been over-dialyzed which was causing them to feel sick.
 
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Brand Name2008K 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
matthew amaral
920 winter st
waltham, MA 02451
7816999758
MDR Report Key9700181
MDR Text Key179234125
Report Number2937457-2020-00297
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K994267
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 02/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/12/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue NumberUNKNOWN- 2008K MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received02/17/2020
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: 02/12/2020 Patient Sequence Number: 1
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