MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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

Patient Problems Death (1802); Myocardial Infarction (1969)

Event Date 02/06/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in progress.A supplemental medwatch report will be submitted upon completion of this activity.

Event Description

It was reported that a patient passed away coincident with hemodialysis dialysis therapy.The patient¿s death certificate listed the cause of death as unknown.The patient¿s death certificate listed the patient to be on continuous ambulatory peritoneal dialysis (capd) treatment, however the peritoneal dialysis registered nurse clarified that the patient was on hemodialysis prior to passing away and not capd.The patient reportedly had a heart attack in their home and was transported to the emergency room via ambulance.The patient was not actively dialyzing at the time of the event.The patient was reported to have completed their hemodialysis treatment successfully on (b)(6) 2018 without any issues noted.Additional information was requested but was not available.

Manufacturer Narrative

Plant investigation: the device was not returned to the manufacturer for physical evaluation and the serial number could not be obtained.As a serial number could not be determined, device history and manufacturing records could not be reviewed.As a physical evaluation could not be performed, a definitive conclusion regarding the reported incident could not be reached and a cause could not be confirmed.Should additional relevant information become available, a supplemental report will be submitted.Clinical investigation: a clinical investigation was performed to identify a causal relationship between the peritoneal dialysis (pd) treatment and the adverse event.Based on the provided information there is no evidence or documentation supporting a possible causal association between hemodialysis (hd) therapy on the 2008k machine, and the patient event(s) of myocardial infarction and subsequent death.Per the registered nurse¿s statement on (b)(6) 2018 the patient had received their last hd treatment on (b)(6) 2018, and was not actively performing renal replacement therapy (rrt) at the time of the event(s).Additionally, there is no documentation or allegation that any fresenius device(s) caused or contributed to the patients¿ myocardial infarction and/or death.It is unknown if any association exists between the patients¿ comorbid conditions and event(s) of myocardial infarction and death.The esrd death notification states the cause of death is unknown.

• Brand Name: 2008K MACHINE
• 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: 7360623
• MDR Text Key: 103128690
• Report Number: 2937457-2018-00856
• Device Sequence Number: 1
• Product Code: KDI
• 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: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Device Age: MO
• Date Manufacturer Received: 03/23/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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; Life Threatening; Required Intervention
• Patient Age: 66 YR