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 Death (1802)

Event Date 01/19/2021

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship does not exist between hd therapy utilizing the 2008t hemodialysis system, and the serious adverse event of death.Per the hospitals doh, the patient was not undergoing hd therapy when he/she expired.The definitive cause of the patients death is unknown; therefore, causality cannot be firmly established.The esrd population continues to have significantly higher mortality, and fewer expected years of life when compared to the general population.Additionally, adults with esrd have mortality rates up to 30-fold higher than the general population.Based on the limited information available, the 2008t hemodialysis system can be disassociated from the events.There is no allegation or objective evidence indicating that a fresenius product or device may have caused or contributed to the patients expiration.Plant investigation: no parts were returned to the manufacturer for physical evaluation.However, a fresenius field service technician (fst) performed an onsite evaluation of the machine.No non-conformances were noted during functional compliance and ultrafiltration testing; no problems were found with the system.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.Upon completion of the fst's evaluation, no problems were detected and the 2008t hd system was returned to service.The investigation into the cause of the reported problem was not able to be confirmed.

Event Description

A biomedical technician (bmt) contacted fresenius technical support to request the onsite evaluation of a 2008t hemodialysis (hd) machine.The bmt reported that an hd patient experienced a serious adverse event following hd therapy (timeline not provided) on (b)(6) 2021.During follow-up, the director of hemodialysis (doh) reported the patient was not actively dialyzing when they expired (specifics not provided).Additionally, it was confirmed the 2008t hd system was sequestered following the events and was serviced by a fresenius representative.The doh stated no non-conformances were noted during functional compliance and ultrafiltration testing, and the 2008t hd system was returned to service.The functional compliance testing was performed per hospital policy, and not due to suspicion of causality.The doh refused to provide any additional information.

• 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: matthew amaral ; 920 winter st; waltham, MA 02451 ; 7816999758
• MDR Report Key: 11324181
• MDR Text Key: 231695373
• Report Number: 2937457-2021-00251
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861102099
• UDI-Public: 00840861102099
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K173972
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 02/12/2021

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 Model Number: 191126
• Device Catalogue Number: 191126
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Initial Date Manufacturer Received: 01/20/2021
• Initial Date FDA Received: 02/12/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/10/2019
• 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): Death