• 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 UNKNOWN-2008; 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 UNKNOWN-2008; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number UNKNOWN- 2008 MACHINE
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Anemia (1706)
Event Date 08/01/2023
Event Type  Death  
Manufacturer Narrative
Clinical review: it is unknown if a temporal relationship exists between hd therapy utilizing the unknown 2008 hemodialysis system and the serious adverse events of anemia and death, as it is unknown when the events occurred.The patient¿s cause of death remains unknown; therefore, causality could not be firmly established.It should be noted that an inability to obtain additional clinical information precluded a more in-depth investigation.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population additionally, adults with esrd have mortality rates up to 30-fold higher than the general population.Based on the information available, the patient¿s unknown 2008 hemodialysis system can be disassociated from the serious adverse events.There is no allegation or objective evidence indicating a fresenius device(s) and/or product(s) caused or contributed to the serious adverse events.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
Fresenius became aware via a social media post (facebook) that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) expired (date not provided).The facebook posting indicated the patient¿s hemoglobin (anemia) and oxygen levels were dropping despite being given iron injections during the past 2 hd treatments.Although the timeline of events is unknown, the patient complained to the reporter that they were feeling unwell and subsequently passed away (specifics unknown).A lack of contact information prevented this reviewer from obtaining any additional information [e.G., discharge summary (if applicable), esrd death notification, autopsy report, treatment data (if applicable), death certificate].
 
Event Description
Fresenius became aware via a social media post (facebook) that this patient with end stage renal disease (esrd) on hemodialysis (hd) for renal replacement therapy (rrt) expired (date not provided).The facebook posting indicated the patient¿s hemoglobin (anemia) and oxygen levels were dropping despite being given iron injections during the past 2 hd treatments.Although the timeline of events is unknown, the patient complained to the reporter that they were feeling unwell and subsequently passed away (specifics unknown).A lack of contact information prevented this reviewer from obtaining any additional information [e.G., discharge summary (if applicable), esrd death notification, autopsy report, treatment data (if applicable), death certificate].
 
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.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
UNKNOWN-2008
Type of Device
DIALYZER, 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
jessica trujillo
920 winter st
waltham, MA 02451
6174175172
MDR Report Key17691389
MDR Text Key322745829
Report Number0002937457-2023-01356
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K150708
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Consumer
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 09/20/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN- 2008 MACHINE
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 09/01/2023
Initial Date FDA Received09/06/2023
Supplement Dates Manufacturer Received09/19/2023
Supplement Dates FDA Received09/20/2023
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 Sequence Number1
Patient Outcome(s) Death;
Patient SexMale
-
-