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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number 190713
Device Problem Fluid Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/07/2022
Event Type  malfunction  
Event Description
The facility administrator (fa) from a hemodialysis (hd) clinic reported that the blood pump rotor tubing guide broke on a fresenius 2008t machine and sliced the blood tubing causing it to leak. Upon follow-up, it was reported that this occurred twice on the same machine, but with separate patients. Each time, the blood pump rotor cut the bloodline tubing approximately one to two hours into hd treatment. The fa stated the blood pump rotor was chafing the tubing and eventually cut through it. Both patients were able to complete their treatment on the machine after being re-setup with new supplies. The fa stated the estimated blood loss (ebl) was 100 ml for each event. Per the fa, the operator had noticed a small amount of blood dripping onto the floor, which alerted them to the issue. The fa stated this was a machine issue, and confirmed that there was nothing wrong with the bloodlines. There were no machine alarms, but none were expected. The fa stated that blood was being pushed out, through the sliced tubing. There were no air detector alarms because ¿no air was being sucked in¿ [sic]. Following the first event, the facility continued using the machine not knowing the blood pump rotor was damaged. However, the same thing happened with the next patient who dialyzed on the machine. After the second blood leak event, further investigation revealed that the blood pump rotor tubing guide broke and sliced the bloodline tubing. It was reported that the facility purchases their blood pump rotors from a third-party vendor (gia medical). The fa stated the blood pump rotor was replaced and this resolved the reported issue. Other than blood loss, it was confirmed there was no patient injury, no adverse effects were experienced, and no medical intervention was required as a result of the reported events. The fa declined to provide any patient information. No sample was available to be returned for evaluation as the damaged rotor was discarded. This report captures the second event.
 
Manufacturer Narrative
The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.
 
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Brand Name2008T HEMODIALYSIS SYS., WITH CDX
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 Key14246989
MDR Text Key290454194
Report Number0002937457-2022-00703
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 User Facility
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 04/28/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? No
Device AgeMO
Date Manufacturer Received04/07/2022
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured08/09/2016
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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