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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
Catalog Number 191126
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Anemia (1706); Hemorrhage/Bleeding (1888)
Event Date 11/30/2023
Event Type  Injury  
Manufacturer Narrative
Plant investigation: the plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is no compelling evidence that minimal blood loss would result in any significant drop in hemoglobin for an adult patient.Additionally, the hd treatment was discontinued due to a concerning sound and not due to an adverse event experienced by the patient.Therefore, it can be concluded a serious injury more than likely did not occur and the reason for the ed visit due to anemia was not due to a deficiency or malfunction of any fresenius product(s) or device(s).
 
Event Description
On 5/dec/2023, during a follow up, a clinic manager reported to fresenius this hemodialysis (hd) patient utilizing the 2008t hd system experienced blood loss due to the discontinuation of an hd treatment as they were sent to the emergency department (ed) for anemia.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the follow up with the clinic manager, it was reported this patient had to discontinue an hd treatment on 30/nov/2023 due to a ¿clacking¿ sound from the hd device that concerned clinic staff.As a result, the patient¿s estimated blood loss was 200 ml, and the patient was sent to the ed for anemia.Patient demographic information, medical interventions provided, laboratory values demonstrating anemia and the patient¿s current disposition were not reported.There was no indication of serious injury and an ed visit due to blood loss of 200 ml would qualify as a precautionary measure.The estimation of blood loss is minimal and would not typically result in a deleterious effect to the patient as this value represents less than half of a typical blood donation.
 
Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.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 not able to be confirmed.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.
 
Event Description
On (b)(6) 2023 during a follow up, a clinic manager reported to fresenius this hemodialysis (hd) patient utilizing the 2008t hd system experienced blood loss due to the discontinuation of an hd treatment as they were sent to the emergency department (ed) for anemia.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the follow up with the clinic manager, it was reported this patient had to discontinue an hd treatment on (b)(6) 2023 due to a ¿clacking¿ sound from the hd device that concerned clinic staff.As a result, the patient¿s estimated blood loss was 200 ml, and the patient was sent to the ed for anemia.Patient demographic information, medical interventions provided, laboratory values demonstrating anemia and the patient¿s current disposition were not reported.There was no indication of serious injury and an ed visit due to blood loss of 200 ml would qualify as a precautionary measure.The estimation of blood loss is minimal and would not typically result in a deleterious effect to the patient as this value represents less than half of a typical blood donation.
 
Manufacturer Narrative
Correction: d10 concomitant medical product and therapy date codes; g3 date received by manufacturer for initial submission should have been 12/05/2023.
 
Event Description
On 5/dec/2023, during a follow up, a clinic manager reported to fresenius this hemodialysis (hd) patient utilizing the 2008t hd system experienced blood loss due to the discontinuation of an hd treatment as they were sent to the emergency department (ed) for anemia.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the follow up with the clinic manager, it was reported this patient had to discontinue an hd treatment on (b)(6) 2023 due to a ¿clacking¿ sound from the hd device that concerned clinic staff.As a result, the patient¿s estimated blood loss was 200 ml, and the patient was sent to the ed for anemia.Patient demographic information, medical interventions provided, laboratory values demonstrating anemia and the patient¿s current disposition were not reported.There was no indication of serious injury and an ed visit due to blood loss of 200 ml would qualify as a precautionary measure.The estimation of blood loss is minimal and would not typically result in a deleterious effect to the patient as this value represents less than half of a typical blood donation.
 
Manufacturer Narrative
Correction: g3 date received by manufacturer for initial submission should have been 11/30/2023.
 
Event Description
On 5/dec/2023, during a follow up, a clinic manager reported to fresenius this hemodialysis (hd) patient utilizing the 2008t hd system experienced blood loss due to the discontinuation of an hd treatment as they were sent to the emergency department (ed) for anemia.There was no specific allegation this event was related to a deficiency or malfunction of any fresenius device(s) or product(s) in the initial reporting.Upon review of the follow up with the clinic manager, it was reported this patient had to discontinue an hd treatment on 30/nov/2023 due to a ¿clacking¿ sound from the hd device that concerned clinic staff.As a result, the patient¿s estimated blood loss was 200 ml, and the patient was sent to the ed for anemia.Patient demographic information, medical interventions provided, laboratory values demonstrating anemia and the patient¿s current disposition were not reported.There was no indication of serious injury and an ed visit due to blood loss of 200 ml would qualify as a precautionary measure.The estimation of blood loss is minimal and would not typically result in a deleterious effect to the patient as this value represents less than half of a typical blood donation.
 
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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 Key18318982
MDR Text Key330387746
Report Number0002937457-2023-01871
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 Health Professional,User Facility
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup,Followup,Followup
Report Date 03/11/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number191126
Was Device Available for Evaluation? No
Device AgeMO
Initial Date Manufacturer Received 12/05/2023
Initial Date FDA Received12/13/2023
Supplement Dates Manufacturer Received12/28/2023
03/08/2024
03/11/2024
Supplement Dates FDA Received01/02/2024
03/08/2024
03/11/2024
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured11/17/2021
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
Treatment
FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS BLOODLINES; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER; FRESENIUS DIALYZER
Patient Outcome(s) Required Intervention; Hospitalization;
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