MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Model Number	190610
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	09/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Clinical investigation: a temporal relationship exists between hd therapy with the fresenius 2008k2 hemodialysis machine and the patient¿s event.The machine will not be returned to manufacturer for device analysis.However, it was reported a biomedical engineer performed a safety check on the machine post incident without any reported allegations of a device malfunction or product issue.The machine was returned to use without any reported issues.Based on the very limited information, the exact cause for the patient incident can not be determined.However, it was reported by the biomedical engineer that the patient had several comorbid conditions that contributed to the event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Event or Problem Description
It was reported the fresenius 2008k2 hemodialysis machine had a safety check performed due to an unspecified patient incident.Additional follow-up was conducted with a biomedical engineer.However, very limited details about the patient event were available.It was stated an unknown patient coded while on the fresenius 2008k2 hemodialysis machine.It was reported as part of clinic policy, the machine is put through a safety check after any incident.The biomedical engineer reported the machine was not suspected to have caused any harm to the patient.It was stated the patient incident was due to patient comorbidities and not related to fresenius product.Per the biomedical engineer, the fresenius 2008k2 hemodialysis machine passed all tests and has returned to use without any issues.No further information was available.
Event or Problem Description
It was reported the fresenius 2008k2 hemodialysis machine had a safety check performed due to an unspecified patient incident.Additional follow-up was conducted with a biomedical engineer.However, very limited details about the patient event were available.It was stated an unknown patient coded while on the fresenius 2008k2 hemodialysis machine.It was reported as part of clinic policy, the machine is put through a safety check after any incident.The biomedical engineer reported the machine was not suspected to have caused any harm to the patient.It was stated the patient incident was due to patient comorbidities and not related to fresenius product.Per the biomedical engineer, the fresenius 2008k2 hemodialysis machine passed all tests and has returned to use without any issues.No further information was available.
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, an on-site evaluation was performed by a fresenius field service technician (fst).The ultrafiltration (uf) checklist was performed including calibration of the uf pump.It was documented that the machine passed all functional testing.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 was not able to confirm the reported failure mode.A causal relationship between the objective evidence and the alleged event could not be determined, therefore the alleged event is unconfirmed.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• Common Device Name: 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: 15602326
• Report Number: 0002937457-2022-01720
• Device Sequence Number: 16713866
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K994267
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/02/2022

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
• Operator of Device: Health Professional
• Device Model Number: 190610
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2022
• Supplement Date Received by Manufacturer: 10/21/2022
• Initial Report FDA Received Date: 10/13/2022
• Supplement Report FDA Received Date: 11/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/04/2009
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown