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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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CONCORD MANUFACTURING 2008T HD SYS. W/O CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Catalog Number 191130
Device Problem Obstruction of Flow (2423)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 11/20/2023
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 hemodialysis (hd) user facility reported that a fresenius 2008t hd machine failed to alarm with a high venous pressure alarm or a high transmembrane pressure (tmp) alarm while a patient was clotting during treatment.Due to the alarm failure, the staff did not realize the patient was clotting and the patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) due to the event was 250 ml.Additional details were provided upon follow-up with the user facility¿s biomedical technician (biomed) and facility administrator (fa).The patient was approximately three hours into their treatment when the issue occurred.It was confirmed that the patient is very prone to clotting - this was not the concerning part.What was concerning was that the machine failed to notify the staff when it began to happen.It was explained that the machines normally alarm with some sort of pressure alarm when a patient is clotting, and that didn¿t happen in this scenario.The patient¿s treatment was discontinued early.It was confirmed the patient did not experience any adverse effects or require medical intervention.The machine was removed from service for testing and evaluated by the biomed.The biomed initially stated there were no problems found during the machine inspection.After further questioning, it was disclosed that a heparin administration issue occurred with the machine.The heparin pump did not deliver the correct dose of heparin to the patient during the treatment.The biomed communicated this information to technical support and was sent a replacement.The biomed said the heparin pump was replaced and the old one was available to be sent back for evaluation.The patient was utilizing a revaclear dialyzer with fresenius bloodlines.However, the fa stated there were no issues with the disposable supplies.It was reiterated that the blood loss occurred because the machine failed to alarm appropriately to notify the operator of the clotting.The machine was confirmed to be back in service and fully functional.
 
Manufacturer Narrative
Plant investigation: although a sample was reported to be available for manufacturer evaluation, to date no parts have been received.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).However, the complaint investigation was able to find objective evidence indicating a product problem, and thus the complaint was confirmed.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.Based on the available information, the complaint was confirmed.
 
Event Description
A hemodialysis (hd) user facility reported that a fresenius 2008t hd machine failed to alarm with a high venous pressure alarm or a high transmembrane pressure (tmp) alarm while a patient was clotting during treatment.Due to the alarm failure, the staff did not realize the patient was clotting and the patient¿s blood could not be returned.The patient¿s estimated blood loss (ebl) due to the event was 250 ml.Additional details were provided upon follow-up with the user facility¿s biomedical technician (biomed) and facility administrator (fa).The patient was approximately three hours into their treatment when the issue occurred.It was confirmed that the patient is very prone to clotting - this was not the concerning part.What was concerning was that the machine failed to notify the staff when it began to happen.It was explained that the machines normally alarm with some sort of pressure alarm when a patient is clotting, and that didn¿t happen in this scenario.The patient¿s treatment was discontinued early.It was confirmed the patient did not experience any adverse effects or require medical intervention.The machine was removed from service for testing and evaluated by the biomed.The biomed initially stated there were no problems found during the machine inspection.After further questioning, it was disclosed that a heparin administration issue occurred with the machine.The heparin pump did not deliver the correct dose of heparin to the patient during the treatment.The biomed communicated this information to technical support and was sent a replacement.The biomed said the heparin pump was replaced and the old one was available to be sent back for evaluation.The patient was utilizing a revaclear dialyzer with fresenius bloodlines.However, the fa stated there were no issues with the disposable supplies.It was reiterated that the blood loss occurred because the machine failed to alarm appropriately to notify the operator of the clotting.The machine was confirmed to be back in service and fully functional.
 
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Brand Name
2008T HD SYS. W/O 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 Key18313906
MDR Text Key330466413
Report Number0002937457-2023-01868
Device Sequence Number1
Product Code KDI
UDI-Device Identifier00840861102112
UDI-Public00840861102112
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
Reporter Occupation Biomedical Engineer
Type of Report Initial,Followup
Report Date 12/29/2023
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 Catalogue Number191130
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Device AgeMO
Initial Date Manufacturer Received 11/22/2023
Initial Date FDA Received12/12/2023
Supplement Dates Manufacturer Received12/12/2023
Supplement Dates FDA Received12/29/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/11/2023
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
FRESENIUS BLOODLINES; FRESENIUS BLOODLINES
Patient Age78 YR
Patient SexMale
Patient Weight119 KG
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