MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HD SYS. CDX W/BIBAG BLUE STAR; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number 191126

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 04/28/2021

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.Clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy utilizing the 2008t hd machine and the patient coding during treatment.There is also a possible causal relationship between the adverse event and use of the machine.After the event, the uf pump was found to not be within range and not passing the positive pressure test on the uf pump during the uf problem identification procedure.It was unknown if the uf issues were related to the patients adverse event.No information related to the patient event was provided other than the patient has recovered and returned to hd therapy without issue.Hemodialysis patients experience high rates of cardiovascular morbidity with the rates for cardiac arrest exceeding those of the general population by 30-fold.Several risk factors have been identified for cardiac arrest including underlying cardiovascular disease, extremes of serum potassium and diabetes.(flythe et al, 2014) although there was no direct allegation that the machine caused the patients cardiac arrest, the machine evaluation has not been completed.Therefore, it cannot be concluded if the 2008t hemodialysis machine caused or contributed to the patients adverse event.Should additional information become available related to a fresenius device(s) and/or product(s), please re-submit for a clinical review and the need for a clinical investigation will be reassessed accordingly.

Event Description

It was reported a hemodialysis (hd) patient coded during treatment on the 2008t hemodialysis machine.The patient did not expire.During the machine evaluation, the ultrafiltration (uf) problem identification procedure failed when the uf pump was not within range while verifying the uf pump stroke calibration.The uf pump was also not passing the positive pressure test on the uf pump.Follow-up was conducted with the hemodialysis clinic manager (cm).The cm stated that the patient was male and that he is currently back to hemodialysis therapy with no issues.His current status is fine.No additional information was provided related to the adverse event or the patient.The biomedical engineer provided information stating the 2008t machine did not alarm during the patients treatment.It was unknown at what point in treatment the patient coded.It could not be confirmed if the uf issue found during evaluation was related to the patient coding on the machine.The machine was still in quarantine as the fresenius regional equipment specialist (res) was scheduled to evaluate the machine.

Manufacturer Narrative

Correction: b5, h10 plant investigation plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius field service technician (fst).During fst evaluation, a problem identification procedure was performed and the machine did not pass the testing procedure.The ultrafiltration check valve was found to be split in half and the component was replaced, which was confirmed by a photograph provided.The machine passed testing and heated appropriately.The manufacturing records associated with the serialized device were reviewed 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 device evaluation performed on site, the alleged adverse event could not be confirmed and a cause was not identified.

Event Description

It was reported a hemodialysis (hd) patient coded during treatment on the fresenius 2008t hemodialysis machine.The patient did not expire.During the machine evaluation, the ultrafiltration (uf) problem identification procedure failed when the uf pump was not within range while verifying the uf pump stroke calibration.The uf pump was also not passing the positive pressure test on the uf pump.Follow-up was conducted with the hemodialysis clinic manager (cm).The cm stated that the patient was male (age, date of birth, and estimated dry weight not provided) and that they are currently back to hemodialysis therapy with no issues.Per the cm, the patient¿s current status is fine.No additional information was provided related to the adverse event or the patient.The biomedical engineer provided information stating the fresenius 2008t machine did not alarm during the patient¿s treatment.It was unknown at what point in treatment the patient coded.It could not be confirmed if the uf issue found during evaluation was related to the patient coding on the machine.The machine was still in quarantine as a fresenius field service technician (fst) was scheduled to evaluate the machine onsite.A field service repair was completed for the hemodialysis (hd) machine, which was serviced by fst.The machine was reported to have 4,900 hours.The fst performed the uf problem identification procedure and the machine did not pass the uf balance error or the uf pump error.The fst found a uf check valve that was split in half.The uf check valve was replaced, and test repeated, however the machine failed balance and pump errors again (test one uf balance error was 100 test two it was 80, test one uf pump error was 60 test two it was 38) and the uf stroke was 24.1.Upon completion of the onsite evaluation by the fresenius fst, the machine passed functional testing and heated appropriately.

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hemodialysis (hd) therapy utilizing the 2008t hd machine and the patient coding during treatment.There is also a possible causal relationship between the adverse event and use of the machine.After the event, the uf pump was found to not be within range and not passing the positive pressure test on the uf pump during the uf problem identification procedure.It was unknown if the uf issues were related to the patient¿s adverse event.No information related to the patient event was provided other than the patient has recovered and returned to hd therapy without issue.Hemodialysis patients experience high rates of cardiovascular morbidity with the rates for cardiac arrest exceeding those of the general population by 30-fold.Several risk factors have been identified for cardiac arrest including underlying cardiovascular disease, extremes of serum potassium and diabetes.Although there was no direct allegation that the machine caused the patient¿s cardiac arrest, the machine evaluation has not been completed.Therefore, it cannot be concluded if the 2008t hemodialysis machine caused or contributed to the patient¿s adverse event.

Event Description

It was reported a hemodialysis (hd) patient coded during treatment on the fresenius 2008t hemodialysis machine.The patient did not expire.During the machine evaluation, the ultrafiltration (uf) problem identification procedure failed when the uf pump was not within range while verifying the uf pump stroke calibration.The uf pump was also not passing the positive pressure test on the uf pump.Follow-up was conducted with the hemodialysis clinic manager (cm).The cm stated that the patient was male (age, date of birth, and estimated dry weight not provided) and that they are currently back to hemodialysis therapy with no issues.Per the cm, the patient¿s current status is fine.No additional information was provided related to the adverse event or the patient.The biomedical engineer provided information stating the fresenius 2008t machine did not alarm during the patient¿s treatment.It was unknown at what point in treatment the patient coded.It could not be confirmed if the uf issue found during evaluation was related to the patient coding on the machine.The machine was still in quarantine as a fresenius regional equipment specialist (res) was scheduled to evaluate the machine onsite.A field service repair was completed for the hemodialysis (hd) machine, which was serviced by res.The machine was reported to have 4,900 hours.The res performed the uf problem identification procedure and the machine did not pass the uf balance error or the uf pump error.The res found a uf check valve that was split in half.The uf check valve was replaced, and test repeated, however the machine failed balance and pump errors again (test one uf balance error was 100 test two it was 80, test one uf pump error was 60 test two it was 38) and the uf stroke was 24.1.Upon completion of the onsite evaluation by the fresenius res, the machine passed functional testing and heated appropriately.

Event Description

It was reported a hemodialysis (hd) patient coded during treatment on the 2008t hemodialysis machine.The patient did not expire.During the machine evaluation, the ultrafiltration (uf) problem identification procedure failed when the uf pump was not within range while verifying the uf pump stroke calibration.The uf pump was also not passing the positive pressure test on the uf pump.Follow-up was conducted with the hemodialysis clinic manager (cm).The cm stated that the patient was male and that he is currently back to hemodialysis therapy with no issues.His current status is fine.No additional information was provided related to the adverse event or the patient.The biomedical engineer provided information stating the 2008t machine did not alarm during the patient¿s treatment.It was unknown at what point in treatment the patient coded.It could not be confirmed if the uf issue found during evaluation was related to the patient coding on the machine.The machine was still in quarantine as the fresenius regional equipment specialist (res) was scheduled to evaluate the machine.A field service repair was completed for the hemodialysis (hd) machine, which was serviced by res.A problem identification procedure was performed and the machine did not pass the testing procedure.The ultrafiltration check valve was found to be split in half and the component was replaced.The machine passed testing and heated appropriately.

Event Description

It was reported a hemodialysis (hd) patient coded during treatment on the fresenius 2008t hemodialysis machine.The patient did not expire.During the machine evaluation, the ultrafiltration (uf) problem identification procedure failed when the uf pump was not within range while verifying the uf pump stroke calibration.The uf pump was also not passing the positive pressure test on the uf pump.Follow-up was conducted with the hemodialysis clinic manager (cm).The cm stated that the patient was male (age, date of birth, and estimated dry weight not provided) and that they are currently back to hemodialysis therapy with no issues.Per the cm, the patient¿s current status is fine.No additional information was provided related to the adverse event or the patient.The biomedical engineer provided information stating the fresenius 2008t machine did not alarm during the patient¿s treatment.It was unknown at what point in treatment the patient coded.It could not be confirmed if the uf issue found during evaluation was related to the patient coding on the machine.The machine was still in quarantine as a fresenius regional equipment specialist (res) was scheduled to evaluate the machine onsite.A field service repair was completed for the hemodialysis (hd) machine, which was serviced by res.The machine was reported to have 4,900 hours.The res performed the uf problem identification procedure and the machine did not pass the uf balance error or the uf pump error.The res found a uf check valve that was split in half.The uf check valve was replaced, and test repeated, however the machine failed balance and pump errors again (test one uf balance error was 100 test two it was 80, test one uf pump error was 60 test two it was 38) and the uf stroke was 24.1.Upon completion of the onsite evaluation by the fresenius res, the machine passed functional testing and heated appropriately.

Manufacturer Narrative

Correction: b5 plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res).During res evaluation, a problem identification procedure was performed and the machine did not pass the testing procedure.The ultrafiltration check valve was found to be split in half and the component was replaced, which was confirmed by a photograph provided.The machine passed testing and heated appropriately.The manufacturing records associated with the serialized device were reviewed 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 device evaluation performed on site, the alleged adverse event could not be confirmed and a cause was not identified.

• 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
• MDR Report Key: 11806095
• MDR Text Key: 249979067
• Report Number: 2937457-2021-01017
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Date Manufacturer Received: 06/09/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention