• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 05/15/2020
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 back pain and ¿feeling on fire¿), loss of consciousness and subsequent death following the administration of vancomycin following hd therapy. Per the xellia (representative reporting the events), the patient¿s nephrologist and fa, 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 hd machine passed all post event functional compliance and ultrafiltration testing and was returned to service by the 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. Follow-up with the patient¿s outpatient dialysis clinic¿s facility administrator (fa) revealed the patient was prescribed post-treatment intravenous (iv) vancomycin 1000 mg due to fevers and flank pain. Within minutes of starting the infusion the patient decompensated. The patient was unstable hypotensive (result not provided) but alert and oriented when emergency medical services (ems) arrived. Once ems arrived and transferred the patient to the stretcher, the patient became unresponsive and was rushed to the ambulance outside. They ¿coded¿ the patient for 30 minutes in the parking lot without success. The patient was pronounced dead at the hospital a short while later. The state performed an extensive investigation into the events, and concluded the patient suffered a severe anaphylactic reaction to the vancomycin. Additionally, the patient¿s past medical history included orthostatic hypotension, and it was concluded the patient suffered another hypotensive event during transfer from which the patient did not recover. Per the received medwatch report, there were no complications during the treatment. The patient was ordered to receive iv vancomycin 1000 mg post-treatment, and minutes after the infusion began the patient reported experiencing back pain and feeling ¿on fire. ¿ the vancomycin was immediately stopped, and the patient was given benadryl 25 mg iv push and normal saline (volume not provided). The patient was responsive still. 911 was contacted, ems arrived, and the patient was transferred to a stretcher. During transfer the patient became unresponsive and subsequently expired. The hd machine was immediately sequestered following the events. Functional compliance and ultrafiltration (uf) testing were completed, and the hd machine performed as per manufacturer specifications. The nephrologist and fa approved returning the hd machine to service following the favorable test results. Additionally, given the state¿s involvement in the case, their approval was also obtained before returning the machine to service. The fa stated they were confident no fresenius product(s), device(s) or drug(s) caused or contributed to the patient¿s expiration. The serial number for the hd machine is unknown as it was not provided during follow-up.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key10754952
MDR Text Key213664137
Report Number2937457-2020-01952
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
-
-