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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); Hypersensitivity/Allergic reaction (1907); Loss of consciousness (2418)
Event Date 09/19/2020
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 event(s) of an anaphylactic reaction (characterized by nausea, restlessness, sweating), loss of consciousness and subsequent death following the administration of vancomycin during hd therapy. Per the xellia representative reporting the events, the patient¿s nephrologist and cm, 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 events experienced by the patient. Furthermore, the hd machine passed all post event functional compliance and ultrafiltration testing.
 
Event Description
It was reported to fresenius that a hemodialysis (hd) patient experienced anaphylactic shock and subsequently expired, 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. Follow-up with the patient¿s outpatient dialysis clinic manager (cm) revealed the patient underwent 3. 0 hours of hemodialysis (hd) without issue. During the last hour of treatment, the patient was ordered to receive iv vancomycin 1000 mg over the last hour of treatment. Approximately 4 to 5 min after the infusion began, the patient became unwell and began to quickly deteriorate. The patient became ¿clammy¿ (sweating) and complained of nausea, restlessness and a feeling of ¿not feeling right. ¿ the vancomycin was stopped and the patient was placed in trendelenburg. 300 ml of normal saline was administered following which the patient became unresponsive. The patient¿s breathing was agonal and 911 was contacted. The patient was given supplementary oxygen (volume not provided) and the automated external defibrillator was applied to the patient. The patient was given iv (push) benadryl 50 mg, after which emergency medical services (ems) arrived and transported the patient to the hospital. The patient remained unresponsive upon leaving the clinic. Although the hospital course is unknown, the medwatch report states the patient expired nine days later. The hd machine was immediately sequestered following the events. Functional compliance and ultrafiltration tests were performed, and the machine operated as per manufacturer specifications. The nephrologist and cm approved returning the hd machine to service following the favorable test results. The cm reported no fresenius product(s) and/or device(s) caused or contributed to the patient¿s demise. 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 Key10755268
MDR Text Key213664222
Report Number2937457-2020-01955
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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