• 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 HD SYS. CDX W/BIBAG BLUE STAR 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 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 Hematoma (1884); Respiratory Failure (2484); Multiple Organ Failure (3261)
Event Date 01/16/2022
Event Type  Death  
Manufacturer Narrative
Clinical investigation: a temporal relationship exists between the patient¿s respiratory failure leading to his death and hd therapy utilizing a hospital provided 2008t hd machine. The root cause of the patient¿s death can be attributed to respiratory failure as reported by a medical professional. It is well known respiratory failure is one of the leading causes of hospital in-patient mortality. Additionally, this patient had multi-organ failure which carries a high risk of mortality for the critically ill and significantly reduced the chance of survival for this patient. Therefore, the 2008t hd machine can be excluded as a source or contributor to this patient¿s adverse event. Based on the required information, there is no specific allegation or objective evidence indicating a fresenius device(s) or product(s) deficiency or malfunction, caused or contributed to the patient¿s adverse event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
Event Description
It was reported that a hemodialysis (hd) patient coded and expired while connected to the 2008t machine. The machine was left unattended with blood lines still attached. The staff was able to run an acid clean & mandatory rinse. During chemical disinfect (bleach), the machine displayed a system leak, can't run message (yellow banner) at the 2 minute counter time. Technical support advised to run a inlet water pressure regulator check, adjust pressure if needed or replace water inlet pressure regulator, swap heat exchanger (might be leaking internally) or possible pressure transducer #9 issue if issue continues. Upon follow up with a hospital hd registered nurse, it was reported this critically ill patient expired during an hd treatment due to respiratory failure while hospitalized. The patient was initially admitted to the hospital on (b)(6) 2022 following a fall with the formation of a large hematoma in the abdomen. The patient was not previously a chronic hd patient but due to the patient¿s rapid deterioration, multi-organ failure occurred including renal failure. The patient was given a second hd treatment on a hospital provided 2008t hd machine on (b)(6) 2022 15 minutes into the hd treatment, the patient went into respiratory failure. It was the decision of the patient¿s family to discontinue life saving measures and the patient expired shortly after a do-not-resuscitate order was placed. It was confirmed the patient¿s death due to respiratory failure was unrelated to hd therapy and not due to a deficiency or malfunction of any fresenius product(s) or device(s).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
jason busch
920 winter st
waltham, MA 02451
9043166958
MDR Report Key13393136
MDR Text Key284701847
Report Number2937457-2022-00144
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 Health Professional,User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 02/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/31/2022
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
Device AgeMO
Date Manufacturer Received01/31/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/20/2018
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: 01/31/2022 Patient Sequence Number: 1
-
-