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 Fluid/Blood Leak (1250)

Patient Problem Cardiac Arrest (1762)

Event Date 08/20/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation was performed by a fresenius regional equipment specialist (res).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 Description

A nurse at a user facility reported a patient went into cardiac arrest while undergoing treatment on a fresenius 2008t hemodialysis machine, which was concurrent with the patient undergoing an unspecified transplant surgery.Due diligence attempts were exhausted, but no additional information was received.

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hemodialysis (hd) therapy utilizing the fresenius 2008t dialysis machine, and the adverse event of cardiac arrest.The impetus for the cardiac arrest is unknown, therefore causality cannot be established.It is known however that chronic kidney disease patients are at high risk for cardiovascular disease (cv) and cv related events.On (b)(6) 2018 the charge nurse stated they did not suspect 2008t machine involvement.However, given the hd treatment and cardiac arrest occurred concurrently; a possible contributory role cannot be ruled out.Additionally, it is also unknown to what extent if any, the blood leak detected alarm contributed to the event.It is known that a variety of circumstances can affect the viability of blood monitoring devices during hd therapy.

• 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: 7845448
• MDR Text Key: 119158634
• Report Number: 2937457-2018-02585
• 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: user facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

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?: 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
• Initial Date Manufacturer Received: 08/22/2018
• Initial Date FDA Received: 09/05/2018
• Supplement Dates Manufacturer Received: 09/06/2018
• Supplement Dates FDA Received: 09/06/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2012
• 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): Life Threatening; Other