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 03/20/2019

Event Type  Death  

Manufacturer Narrative

Clinical investigation: there is a temporal relationship between hd treatment on the 2008k2 machine and the patient death.However, there is no documentation in the file to show a causal relationship between the machine and the death.Additionally, there is no allegation of a machine malfunction reported for this event.The machine alarmed appropriately alerting the staff to a pressure issue when the patient went unresponsive and expired.A cause of death has not been determined at this time.The patient¿s comorbid conditions are unknown, but dialysis patients are at a high risk for death with cardiac disease as the major cause.Plant investigation: no parts were returned to the manufacturer for physical evaluation.An on-site evaluation was performed by a fresenius regional equipment specialist (res), who confirmed the machine functioned correctly without issue, and passed all functional tests.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-conformance, 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.

Event Description

On (b)(6) 2019 the biomedical engineer (biomed) for a hemodialysis (hd) clinic contacted fresenius technical support to report that a patient expired during treatment on (b)(4) 2019 utilizing the fresenius 2008k2 machine.The biomed requested a machine evaluation 6 additional information was received (b)(6) 2019 during follow up with the hd clinic manager.Per the manager, the patient was in treatment when the venous and arterial pressure alarms sounded and alerted the staff.The patient was found unresponsive and had a ¿do not resuscitate (dnr)¿ and ¿do not intubate (dni)¿ order, therefore no resuscitative efforts were performed, and the patient expired.The machine was evaluated and put back in service after passing all machine functional testing.Additional patient information was requested, but was not received.If additional information is received, a supplemental report will be submitted.

• 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
• 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: 8481944
• MDR Text Key: 140872502
• Report Number: 2937457-2019-00985
• Device Sequence Number: 1
• Product Code: KDI
• UDI-Device Identifier: 00840861100859
• UDI-Public: 00840861100859
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2019
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 190610
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Device Age: MO
• Date Manufacturer Received: 03/21/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2010
• 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