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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 190610
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Cardiac Arrest (1762)
Event Date 10/01/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a clinical investigation was performed. A temporal relationship exists between hd therapy utilizing the 2008k2 hemodialysis system, and the adverse event of cardiac arrest. Although the patient was connected to the 2008k2 hemodialysis system when the event occurred, there is no allegation indicating a fresenius product deficiency or malfunction caused or contributed to the patient¿s cardiac arrest. The occurrence of cardiac arrest in hd patients is low considering the complex nature of the procedure. However, given the results of the functional compliance testing and the absence of treatment records and/or hospitalization summary; the 2008k2 hemodialysis system cannot be excluded from having a possible causal or contributory role in the patient¿s cardiac arrest, as there is insufficient evidence to conclude otherwise. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility biomedical technician (biomed) reported that a hemodialysis patient coded. An evaluation of the machine was requested due to the patient coding during treatment on the 2008k2. A fresenius regional equipment specialist (res) performed an on-site evaluation of the machine. A loading pressure regulator was found leaking. The regulator pressure was replaced. The ultrafiltration strokes were checked and found to be out of range, on the high side. The ultrafiltration pump was recalibrated. Upon follow up, the inpatient program manager (ipm) confirmed the patient suffered a cardiac arrest during hd therapy (specifics not provided). The patient reportedly survived the event and remains in the intensive care unit (icu). The ipm reported the patient is in acute kidney failure (akf) and was not receiving any form of renal replacement therapy prior to admission. Additional information was requested, however not provided.
 
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Brand Name2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
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 Key9162518
MDR Text Key161703752
Report Number2937457-2019-03123
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 health professional,user faci
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 10/30/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/07/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received10/28/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/23/2009
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: 10/07/2019 Patient Sequence Number: 1
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