MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYS., WITH CDX; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190713

Device Problem Inadequate Ultra Filtration (1656)

Patient Problem Insufficient Information (4580)

Event Date 04/11/2024

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.  clinical review: based on the available information, the 2008t hemodialysis system can be disassociated from having a causal and/or contributory role in the adverse events experienced by the patient.There is no allegation or objective evidence indicating a serious injury, patient death, or other serious adverse event(s) related to a fresenius device(s) and/or product(s) deficiency or malfunction occurred.Furthermore, there was no report a fresenius device(s) and/or product(s) failed to meet the users¿ expectations or manufacturers¿ specifications.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the ultrafiltration (uf) goal changed from 300 ml to 3000 ml with no staff intervention during the patient's hemodialysis (hd) treatment on the 2008t machine.It was reported the patient completed treatment without experiencing an adverse event, serious injury, or requiring medical intervention.Additional information was obtained during follow-up with the biomed and a user facility nurse.The nurse clarified that the issue resulted from operator error.The staff member who programmed the patient¿s treatment typed 300 ml instead of 3000 ml as the intended ultrafiltration (uf) goal.The error was not noted until treatment completion when the patient pulled the programmed 300 ml.The patient did not experience any symptoms or adverse events as a result of the reported issue.The patient returned to the clinic on a different day for an additional treatment to remove the fluid that was not taken in the original treatment.The biomed stated that the machine was removed from service for testing following the reported event.A simulated ultrafiltration (uf) treatment was completed without issue.No issues were identified and no parts were replaced.The machine has been released for service.No samples will be returned to the manufacturer for physical evaluation.

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 complaint investigation did not find objective evidence indicating a product problem, thus the complaint is unconfirmed.

Event Description

A user facility biomedical technician (biomed) reported to fresenius technical services that the ultrafiltration (uf) goal changed from 300 ml to 3000 ml with no staff intervention during the patient's hemodialysis (hd) treatment on the 2008t machine.It was reported the patient completed treatment without experiencing an adverse event, serious injury, or requiring medical intervention.Additional information was obtained during follow-up with the biomed and a user facility nurse.The nurse clarified that the issue resulted from operator error.The staff member who programmed the patient¿s treatment typed 300 ml instead of 3000 ml as the intended ultrafiltration (uf) goal.The error was not noted until treatment completion when the patient pulled the programmed 300 ml.The patient did not experience any symptoms or adverse events as a result of the reported issue.The patient returned to the clinic on a different day for an additional treatment to remove the fluid that was not taken in the original treatment.The biomed stated that the machine was removed from service for testing following the reported event.A simulated ultrafiltration (uf) treatment was completed without issue.No issues were identified and no parts were replaced.The machine has been released for service.No samples will be returned to the manufacturer for physical evaluation.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• 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 Key: 19136240
• MDR Text Key: 340565886
• Report Number: 0002937457-2024-00642
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150708
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 05/22/2024

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 04/11/2024
• Initial Date FDA Received: 04/18/2024
• Supplement Dates Manufacturer Received: 05/22/2024
• Supplement Dates FDA Received: 05/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/04/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR
• Patient Sex: Female
• Patient Weight: 91 KG