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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
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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 Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/05/2022
Event Type  malfunction  
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Event Description
A fresenius field service technician (fst) was called onsite after a usr facility biomedical technician (biomed) reported that the blood pump rotor guide on a 2008t machine came off and cut into bloodline tubing during the patient's hemodialysis (hd) treatment.It was stated upon initial reporting that the patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient was transferred to another machine where treatment completed successfully with new supplies (brands unknown).The fst replaced the rotor to resolve the reported issue.The machine passed functional testing and was returned to the customer.The sample is available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.
 
Manufacturer Narrative
Plant investigation: a complaint sample was returned to the manufacturer for physical evaluation.The blood pump rotor was returned with slightly loose guide sheaves (guide sleeves) on both rear tubing guide pins, however the sleeves could not be removed from the pin.There are signs of debris (shavings) on the rear guide pins from the guide sheaves.There is no deformation on the rear guide sheaves.No discrepancies were found on both front guide pins and sheaves.A missing ball bearing was encountered, which caused the locking lever to be loose.The rotor was installed into the blood pump module in as-received condition for testing.The returned rotor did not puncture the bloodline and there were no leaks during testing.The rear guide sheaves remained intact and did not fall off the pins.There was no damaged or deformation on the rear guide sheaves during testing.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 investigation into the cause of the reported problem was able to confirm the reported failure mode.
 
Event Description
A fresenius field service technician (fst) was called onsite after a usr facility biomedical technician (biomed) reported that the blood pump rotor guide on a 2008t machine came off and cut into bloodline tubing during the patient's hemodialysis (hd) treatment.It was stated upon initial reporting that the patient did not experience a serious injury or require medical intervention as a result of the reported issue.The patient was transferred to another machine where treatment completed successfully with new supplies (brands unknown).The fst replaced the rotor to resolve the reported issue.The machine passed functional testing and was returned to the customer.The sample is available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.
 
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Brand Name
2008T HD SYS. CDX W/BIBAG BLUE STAR
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 Key15692548
MDR Text Key306882423
Report Number0002937457-2022-01816
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102099
UDI-Public00840861102099
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 User Facility,Company Representative
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 11/11/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/28/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Device Returned to Manufacturer
Is the Reporter a Health Professional? Yes
Device AgeMO
Date Manufacturer Received11/01/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/19/2021
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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