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

Catalog Number	191128
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/01/2024
Type of Reportable Event	Death
Event or Problem Description
A biomedical technician contacted fresenius technical support to request an inspection of the 2008t hemodialysis (hd) machine after a hospital patient passed away during dialysis treatment.The patient¿s doctor had ordered hd as the patient was in very bad health (unspecified).At the last minute of treatment, the patient flatlined and passed away.There were no issues during the dialysis treatment (no alarms or machine issues).There were no reported patient complaints or problems.Attempts to obtain additional information were unsuccessful.
Additional Manufacturer Narrative
Clinical review: there is a temporal relationship between hemodialysis treatment utilizing the 2008t hd machine and the patient event of death.However, there is no documentation in the complaint file to show a causal relationship between the death and use of the 2008t machine.Additionally, there is no allegation of a device malfunction or deficiency reported for this event.The patient was in the hospital for unknown reasons and the physician ordered hemodialysis due to the patient¿s reported bad health status.Acute kidney injury, which leads to a sudden decline in kidney function, is a common and serious complication of hospitalization in the adult population with mortality rates from 45-70%.The patient expired during the treatment, but no issues with the patient or treatment were reported.Based on the available information and no allegation or evidence of a malfunction or deficiency, the fresenius 2008t hemodialysis machine can be excluded as the cause of the patient¿s death.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity. .
Additional Manufacturer Narrative
Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius field service technician (fst).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 or Problem Description
A biomedical technician contacted fresenius technical support to request an inspection of the 2008t hemodialysis (hd) machine after a hospital patient passed away during dialysis treatment.The patient¿s doctor had ordered hd as the patient was in very bad health (unspecified).At the last minute of treatment, the patient flatlined and passed away.There were no issues during the dialysis treatment (no alarms or machine issues).There were no reported patient complaints or problems.Attempts to obtain additional information were unsuccessful.
Additional Manufacturer Narrative
Correction: b3 (event date).
Event or Problem Description
A biomedical technician contacted fresenius technical support to request an inspection of the 2008t hemodialysis (hd) machine after a hospital patient passed away during dialysis treatment.The patient¿s doctor had ordered hd as the patient was in very bad health (unspecified).At the last minute of treatment, the patient flatlined and passed away.There were no issues during the dialysis treatment (no alarms or machine issues).There were no reported patient complaints or problems.Attempts to obtain additional information were unsuccessful.

• Brand Name: 2008T HD SYS. W/O CDX BLUE STAR
• 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: 18519412
• Report Number: 0002937457-2024-00086
• Device Sequence Number: 12450304
• Product Code: KDI
• UDI-Device Identifier: 00840861102105
• UDI-Public: 00840861102105
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K173972
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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?: No
• Operator of Device: Health Professional
• Device Catalogue Number: 191128
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/03/2024
• Supplement Date Received by Manufacturer: 01/30/2024; 03/08/2024
• Initial Report FDA Received Date: 01/16/2024
• Supplement Report FDA Received Date: 01/31/2024; 03/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/19/2019
• 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: Death; Hospitalization
• Patient Sex: Unknown