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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/Blood 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.
 
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
Additional information: this complaint captures the second blood loss event.Please also see associated mdr (mfr report #: 2937457-2022-00702).Plant investigation: no parts were returned to the manufacturer for physical evaluation and an on-site evaluation was not performed by a fresenius field service technician (fst).However, a photograph of the sample was provided.The manufacturer was able to determine a causal relationship between the objective evidence provided by the customer and the reported event.A records review was performed on the reported serial number.An investigation of the device manufacturing records was conducted by the manufacturer.There were no non-conformances, or any associated rework identified during the manufacturing process which could be related to the reported event.In addition, the device history record (dhr) review confirmed the results of the in-progress and final quality control (qc) testing met all requirements.The reported event has been confirmed.
 
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Brand Name
2008T HEMODIALYSIS SYS., WITH CDX
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
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
UDI-Device Identifier00840861100897
UDI-Public00840861100897
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,Followup
Report Date 01/30/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number190713
Device Catalogue Number190713
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 04/07/2022
Initial Date FDA Received04/28/2022
Supplement Dates Manufacturer Received01/25/2023
Supplement Dates FDA Received01/30/2023
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
Patient Sequence Number1
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