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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T MACHINE DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008T MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Dyspnea (1816); Loss of consciousness (2418); Diaphoresis (2452)
Event Date 01/21/2020
Event Type  Death  
Manufacturer Narrative
Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained. As a serial number could not be determined, device history and manufacturing records could not be reviewed. As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed. Should additional relevant information become available, a supplemental report will be submitted.   clinical investigation: a temporal relationship exists between hd therapy utilizing the fresenius 2008t hemodialysis machine and the serious adverse events of an anaphylactic reaction (characterized by eyes widening, diaphoresis and dyspnea), loss of consciousness and subsequent death following the administration of vancomycin following hd therapy. Per the xellia (representative reporting the events), the patient¿s biomedical/medical team concluded no fresenius product(s) and/or device(s) caused or contributed to the patient¿s serious adverse events or death. Anaphylaxis is a rare and life-threatening allergic reaction, which can be caused by severe drug reactions. Based on the information available, the fresenius 2008t hemodialysis machine can be disassociated from the events. There is no allegation or objective evidence indicating a fresenius product(s) or device(s) deficiency or malfunction, caused or contributed to the serious adverse event(s) experienced by the patient. Furthermore, the 2008t hemodialysis machine passed all post event functional compliance and was returned to service by the biomedical/medical team.
 
Event Description
It was reported to fresenius that a hemodialysis (hd) patient experienced anaphylactic shock and subsequently expired, post-treatment after receiving intravenous (iv) vancomycin (not a fresenius product). A medwatch report received from xellia (manufacturer) stated the events were unrelated to any fresenius products. Following treatment, the patient reportedly complained of chills, and the nephrologist ordered blood cultures and an intravenous (iv) dose of vancomycin 2000 mg. Within minutes of beginning the infusion, the patient experienced facial flushing, eyes widening, diaphoresis, trouble breathing (dyspnea) and subsequently lost consciousness. The vancomycin infusion was immediately stopped, and cardiopulmonary resuscitative (cpr) measures were instituted. 911 was contacted, emergency medical services (ems) arrived, and the patient was transported to the hospital. Although the hospital course is largely unknown, the medwatch states the patient expired four days later. Additional details were provided via follow-up with the user facility. The hd machine was immediately sequestered following the events. Functional compliance testing was performed on the 2008t hd machine as per manufacturer specifications. The biomedical/medical team approved returning the 2008t hemodialysis machine to service following the favorable test results. It was concluded no fresenius product(s) and/or device(s) caused or contributed to the patient¿s serious adverse events. Additionally, monthly culture and endotoxin levels collected at the hospital returned showing no growth. The serial number for the hd machine is unknown as it was not provided during follow-up.
 
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Brand Name2008T MACHINE
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 Key10754565
MDR Text Key213639018
Report Number2937457-2020-01951
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 10/29/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/29/2020
Is this an Adverse Event Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN- 2008T MACHINE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA?
Device AgeMO
Event Location No Information
Date Manufacturer Received10/09/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 10/29/2020 Patient Sequence Number: 1
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