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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 05/29/2019
Event Type  Injury  
Manufacturer Narrative
Clinical review: a clinical investigation was performed. There is a temporal relationship between hd therapy on the 2008k2 machine and the patient event of cardiac arrest as the patient was in active treatment at the time. However, there is no documentation in the file to show a causal relationship. Additionally, there is no allegation of a machine malfunction or deficiency related to this event. The patient was in the icu and very unstable prior to initiation of treatment. There were no issues documented with the machine or the treatment. Although the patient was resuscitated, she remains in the icu and has not continued with renal replacement therapy. The facility does not require a manufacturer machine evaluation to be completed. Based on the available information the 2008k2 machine can be excluded as the cause of the patient¿s adverse event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
A user facility's biomedical technician (bmt) reported to technical support that a patient coded on a 2008k hemodialysis system. Upon follow-up with the hd nurse, the patient was in the intensive care unit (icu) for undisclosed reasons. The patient was very unstable prior to initiation of hd treatment on (b)(6) 2019 utilizing the fresenius 2008k2 hd machine. During the treatment (time unknown), the patient coded. The patient was resuscitated (details not provided) and the treatment was not completed. The patient remains in the icu, however, has not continued with renal replacement therapy since the event. There were no machine issues during the treatment and the machine did not require evaluation by a fresenius regional equipment specialist. No further information could be 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
7816999499
MDR Report Key8669882
MDR Text Key147029689
Report Number2937457-2019-01782
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 06/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Catalogue Number190610
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device Age MO
Event Location No Information
Date Manufacturer Received06/14/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured04/02/2012
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: 06/05/2019 Patient Sequence Number: 1
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