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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Death (1802); Nausea (1970)

Event Date 09/11/2018

Event Type  Death  

Manufacturer Narrative

Plant investigation: a fresenius regional equipment specialist (res) later inspected the machine, which passed all functional tests without issue.The machine returned to service.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.Clinical investigation: there is a temporal relationship between hd therapy on the 2008t machine and the patient complaint of nausea with subsequent cardiac arrest and death.There is no documentation to show a causal relationship between the adverse event and the 2008t machine.Additionally, there is no allegation of a machine malfunction or deficiency reported for this event.The machine was evaluated and returned to service with no issues found.Based on available information the cause of the nausea and subsequent cardiac arrest and death cannot be confirmed.

Event Description

A user facility reported a patient who "complaint" of nausea 1.5 hours into their (b)(6) 2018 hemodialysis treatment on a fresenius 2008t machine.Upon follow up with the clinic manager, it was learned that the patient was brought to the hospital and subsequently expired on (b)(6) 2018 due to cardiac arrest.A fresenius regional equipment specialist (res) later inspected the machine, which passed all functional tests without issue, and confirmed the machine returned to service.

• Brand Name: 2008T HEMODIALYSIS SYS., WITH CDX
• Type of Device: DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer (Section G): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: thomas c. johnson ; 920 winter st.; waltham, MA 02451 ; 7816999499
• MDR Report Key: 7910370
• MDR Text Key: 121762697
• Report Number: 2937457-2018-02877
• 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: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 09/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 09/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/03/2018
• 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): Death; Hospitalization
• Patient Age: 65 YR
• Patient Weight: 48