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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 191126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Loss of consciousness (2418); Insufficient Information (4580)
Event Date 06/10/2021
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hd system, and the serious adverse events of, pulselessness, loss of consciousness and subsequent death, as the patient was actively undergoing hd therapy when the events began. The definitive cause of the patients death is unknown; therefore, causality cannot be established. The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population. Based on the totality of the information available, the 2008t hd system cannot be excluded from having a possible contributory role in the patients death. There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) deficiency or malfunction occurred. However, the patient was actively undergoing hd therapy when he expired. Therefore, without a death certificate, esrd death notification, discharge summary and/or autopsy report, this clinical investigation cannot disassociate the device from the serious adverse events. Plant investigation: no parts were returned to the manufacturer for physical evaluation. Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res). 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-conformances, 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. The investigation into the cause of the reported problem was not able to be confirmed. A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
It was reported to fresenius that this patient with end stage renal disease (esrd) was found pulseless during hd therapy on (b)(6) 2021. Follow-up with the user facilitys facility administrator (fa) revealed the patient arrived for their regularly scheduled treatment in stable condition (alert, oriented, no pain, no distress and/or complaints). The patients vitals were within normal limits (blood pressure
=
118/80, pulse
=
78, respirations
=
20, temperature
=
98. 0, weight
=
95. 0 kgs) upon initiation of treatment at 5:30 am. The treatment was progressing without issue until 8:17 am when an arterial alarm sounded on the 2008t hd system. While a patient care technician (pct) was attempting to reestablish arterial blood flow, the patient care technician (pct) noted the patient was cold to the touch and alerted a registered nurse. At 8:19 am the patient was found to be pulseless, not breathing, and cardiopulmonary resuscitative (cpr) measures were initiated. The patients extracorporeal blood was returned, the patient was given 600 ml of normal saline, and emergency medical services (ems) were contacted. At 8:20 am an automated external defibrillator (aed) was placed on the patient in addition to 15 liters of oxygen. At 8:22 am, the aed advised no shock and cpr was resumed until ems arrived at 8:29 am. Ems assumed care of the patient and at 8:40 an intraosseous iv was established, 500 ml of normal saline was administered, and advanced life support (als) measures were instituted. The patient was given rescue medication (drugs not provided) and was intubated at 8:42 am. At 8:46 am the patient was taken to the hospital by ems while als continued. Upon arrival to the hospital the patient was pronounced dead (specifics not provided). The 2008t hd system was sequestered following the event and the user facility biomedical technician (bmt) performed functional compliance testing as required post adverse event. The testing/verification was completed, and the device performed as expected per the manufacturers specifications. During follow-up communication with the user facilitys facility administrator (fa), it was reported the 2008t hd system did not cause or contribute to the events, nor was there any malfunction or deficiency of a fresenius device(s) or product. The discharge summary, death certificate, esrd death notification and autopsy report were requested, however the documents have not been received by the user facility; therefore, the patients cause of death remains unknown.
 
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Brand Name2008T HD SYS. CDX W/BIBAG BLUE STAR
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 Key12089819
MDR Text Key259100975
Report Number2937457-2021-01357
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K173972
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Biomedical Engineer
Type of Report Initial
Report Date 06/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/29/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received06/10/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured10/08/2018
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: 06/29/2021 Patient Sequence Number: 1
Treatment
FRESENIUS OPTIFLUX 160NRE DIALYZER
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