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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 12/12/2022
Event Type  malfunction  
Event Description
A user facility biomedical technician (biomed) reported that the blood pump rotor on a fresenius 2008t machine cut the bloodlines during a patient's hemodialysis (hd) treatment resulting in blood loss.The biomed stated that the reported issue was caused from the blood pump rotor falling apart.The blood pump rotor has been replaced to the resolve the reported issue.The sample is available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.There is no indication from the provided information that the patient experienced a serious injury or required medical intervention as a result of the reported issue.
 
Manufacturer Narrative
The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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.It was determined during the investigation that a causal relationship exists between the objective evidence and the alleged event; therefore the alleged event is confirmed.
 
Event Description
A user facility biomedical technician (biomed) reported that the blood pump rotor on a fresenius 2008t machine cut the bloodlines during a patient's hemodialysis (hd) treatment resulting in blood loss.The biomed stated that the reported issue was caused from the blood pump rotor falling apart.The blood pump rotor has been replaced to the resolve the reported issue.The sample is available to be returned to the manufacturer for physical evaluation.Additional information was requested however a response was not received.There is no indication from the provided information that the patient experienced a serious injury or required medical intervention as a result of the reported issue.
 
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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 Key16078142
MDR Text Key308480427
Report Number0002937457-2022-02225
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 01/12/2023
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 Number191126
Device Catalogue Number191126
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 12/12/2022
Initial Date FDA Received12/30/2022
Supplement Dates Manufacturer Received01/03/2023
Supplement Dates FDA Received01/12/2023
Was Device Evaluated by Manufacturer? No
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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