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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 Death (1802)
Event Date 03/20/2019
Event Type  Death  
Manufacturer Narrative
Clinical investigation: there is a temporal relationship between hd treatment on the 2008k2 machine and the patient death. However, there is no documentation in the file to show a causal relationship between the machine and the death. Additionally, there is no allegation of a machine malfunction reported for this event. The machine alarmed appropriately alerting the staff to a pressure issue when the patient went unresponsive and expired. A cause of death has not been determined at this time. The patient¿s comorbid conditions are unknown, but dialysis patients are at a high risk for death with cardiac disease as the major cause. Plant investigation: no parts were returned to the manufacturer for physical evaluation. An on-site evaluation was performed by a fresenius regional equipment specialist (res), who confirmed the machine functioned correctly without issue, and passed all functional tests. A records review was performed on the reported serial number. An investigation of the device manufacturing records was conducted by the manufacturer. There were no non-conformance, or any associated rework identified during the manufacturing process which could be related to the reported event. In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.
 
Event Description
On (b)(6) 2019 the biomedical engineer (biomed) for a hemodialysis (hd) clinic contacted fresenius technical support to report that a patient expired during treatment on (b)(4) 2019 utilizing the fresenius 2008k2 machine. The biomed requested a machine evaluation 6 additional information was received (b)(6) 2019 during follow up with the hd clinic manager. Per the manager, the patient was in treatment when the venous and arterial pressure alarms sounded and alerted the staff. The patient was found unresponsive and had a ¿do not resuscitate (dnr)¿ and ¿do not intubate (dni)¿ order, therefore no resuscitative efforts were performed, and the patient expired. The machine was evaluated and put back in service after passing all machine functional testing. Additional patient information was requested, but was not received. If additional information is received, a supplemental report will be submitted.
 
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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 Key8481944
MDR Text Key140872502
Report Number2937457-2019-00985
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861100859
UDI-Public00840861100859
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 company representative,user f
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 04/04/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/04/2019
Is this an Adverse Event Report? Yes
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 Received03/21/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/15/2010
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: 04/04/2019 Patient Sequence Number: 1
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