MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Death (1802)

Event Date 06/12/2019

Event Type  Death  

Manufacturer Narrative

Clinical review: a clinical investigation was performed.A temporal relationship exists between the hemodialysis treatment with the fresenius 2008 k2 dialysis machine and the patient¿s cardiac dysrhythmia of ventricular tachycardia which required transfer to the icu where the patient subsequently expired.However, there is no reported allegation nor any objective evidence that a fresenius 2008 k2 dialysis machine malfunction or product deficiency was associated with this event.Based on the available information, the exact cause of the patient¿s death cannot be determined.While there was concomitant use of the fresenius 2008 k2 machine for hemodialysis when the patient had ventricular tachycardia, it was reported the patient¿s death was not unexpected in nature.The patient had a long-standing medical history of cardiac conduction disorder for which the patient underwent an unknown cardiac procedure in the cardiac catheterization lab just prior to the hemodialysis treatment.Cardiac procedures often carry risk for cardiac related events such as damage to cardiac/vascular structures, irregular heart rhythms and heart attack.Therefore, the patient¿s cardiac conduction disorder and the cardiac procedure itself are likely confounding factors in this death event.The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

A user facility nurse manager reported a patient was taken off a 2008k2 fresenius machine during hemodialysis (hd) treatment.The patient was removed from the fresenius 2008 k2 dialysis machine and transferred to the intensive care unit (icu) for further medical intervention.Upon follow up, the nurse manager associated with the dialysis clinic it was discovered this patient has a past medical history of long-standing cardiac conduction disorder.According to the nurse manager, this patient was sent directly to the hemodialysis unit just after having an unknown cardiac procedure in the cardiac catheterization lab.Reportedly, during the hemodialysis treatment the patient went into ventricular tachycardia (vt) rhythm.The patient¿s hemodialysis treatment was terminated, and the patient was transferred to the icu.Additional details surrounding the patient hemodialysis treatment are unknown; although requested.The nurse manager stated the patient subsequently passed away in the icu.Details surrounding the events leading up to the patient¿s death in the icu are unknown.The exact cause of death was not reported.However, the nurse manager indicated it was not unexpected in nature and it was reported the cardiac event was not related to hemodialysis.The nurse manager also stated the fresenius 2008 k2 dialysis machine (in use during the reported event) underwent further testing.Documentation on the service confirmation form date (b)(6) 2019 verified proper operation of the fresenius 2008 k2 dialysis machine and reportedly the machine was returned into service.No further information is currently available, as the nurse manager was not able to provide any more details; although requested.

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A fresenius field service technician (fst) performed an on-site inspection the 2008k2 machine and verified the proper operation of the machine.The machine was 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.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.

• Brand Name: 2008K2 HEMODIALYSIS SYS. OLC/DIASAFE PLS
• 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: 8747650
• MDR Text Key: 149615629
• Report Number: 2937457-2019-02039
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: No
• Device Age: MO
• Initial Date Manufacturer Received: 06/12/2019
• Initial Date FDA Received: 07/01/2019
• Supplement Dates Manufacturer Received: 07/12/2019
• Supplement Dates FDA Received: 07/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death