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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 05/02/2019
Event Type  Death  
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .
 
Event Description
On (b)(6) 2019, fresenius was made aware a patient expired while initiating hemodialysis (hd) on (b)(6) 2019. Per the charge nurse (cn), the patient was critically ill with multiple comorbid conditions which caused the patient¿s death. Reportedly the patient¿s treatment had not fully commenced when the patient expired. The charge nurse confirmed the fresenius 2008k2 machine used for treatment was sequestered per hospital policy, but no findings were expected. Based on the information available, 2008k2 hemodialysis machine is dissociated from the event, as there is no allegation or objective evidence indicating a 2008k2 hemodialysis machine product deficiency or malfunction caused or contributed to the patient¿s death. Additional information regarding the patient and the event was requested, however, not provided by the hospital.
 
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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 Key8646796
MDR Text Key146261838
Report Number2937457-2019-01697
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 Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/28/2019
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue Number190610
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 Received05/30/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured07/16/2010
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: 05/28/2019 Patient Sequence Number: 1
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