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 Problem Cardiac Arrest (1762)

Event Date 01/22/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed by a fresenius regional equipment specialist (res).The unit was pulled from service for evaluation by the user facility area technical operations manager (atom) following the event.The machine did not require any repairs and was confirmed to be operating properly.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 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 patient incident was not able to confirm a device issue which would have resulted in the adverse event.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.

Event Description

An area technical operations manager (atom) at a user facility reported that a patient had a cardiac arrest during hemodialysis (hd) treatment while on a fresenius 2008t hd machine.There were no diagnostic messages or audible alarms.The atom stated that the patient was taken to the hospital and did not complete hd treatment.No further information regarding the patient status has been made available.There were no reported problems during the patient treatment prior to the event.Following the event, the machine was removed from service for evaluation by the user facility¿s atom.The atom ran simulated use testing and all functional and ultrafiltration testing on the machine and no problems were identified.The atom verified machine operations.No repairs were required.The machine remains out of service pending culture results.No defect or malfunction of any fresenius product in use during the hd treatment was observed or identified.No devices were stated to be available to be returned to the manufacturing plant for physical evaluation.

Manufacturer Narrative

Additional information: there is no documentation to show a causal relationship between the patient event of cardiac arrest and the 2008t hemodialysis (hd) machine.Additionally, there is no allegation of a machine malfunction.However, there is a temporal relationship between hd therapy on the 2008t machine and the cardiac arrest as the patient was completing treatment at the time of the event.Per the biomedical technician, the machine passed all testing after the event.It is unknown if the patient had comorbidities or was taking any medication that could have caused or contributed to the cardiac arrest.Based on available information, the cause of the cardiac arrest is unknown.

• 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
• MDR Report Key: 7265993
• MDR Text Key: 99885659
• Report Number: 2937457-2018-00434
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100897
• UDI-Public: 00840861100897
• Combination Product (y/n): N
• PMA/PMN Number: K093902
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 03/07/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• 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
• Device Age: MO
• Date Manufacturer Received: 02/20/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention