MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008T HEMODIALYSIS SYSTEM WITHOUT CDX DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

Catalog Number 190858

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

Patient Problems Cardiac Arrest (1762); Death (1802)

Event Date 11/17/2018

Event Type  Death  

Manufacturer Narrative

Clinical investigation: a temporal relationship exists between hd therapy utilizing the 2008t hemodialysis system without cdx and the event(s) of hypotension, cardiac arrest and subsequent death. The hdrn stated the cause of death was cardiac arrest, and reported the patient had a past medical history including cardiovascular disease. Cardiovascular morbidity and mortality are known to be significantly higher in esrd patients, when compared to the general population. Based on the information available the 2008t hemodialysis system without cdx can be disassociated from the event, as there is no evidence or indication a fresenius product(s) or device(s) caused or contributed to a serious adverse event. Additionally, there is no allegation or evidence of a machine malfunction or of the machine failing to perform as expected in relation to the event. It was reported the 2008t hemodialysis system without cdx passed all function compliance testing following the event. Should additional information become available, the need for a clinical investigation will be re-evaluated accordingly.

Event Description

On (b)(6) 2018, a user facility hemodialysis registered nurse [hd(rn)] called fresenius technical support regarding this (b)(6) male patient with end stage renal disease (esrd) on hemodialysis (hd) thrice weekly for renal replacement therapy (rrt) experiencing hypotension, cardiac arrest and subsequent death during hd therapy on (b)(6) 2018. During follow-up on (b)(6) 2018, the hdrn stated the patient was hypotensive (timeline and values not provided) and subsequently ¿coded¿ (details not provided) approximately 1. 0 hour into treatment. The patient¿s blood was returned, and the treatment was terminated. Cardiopulmonary resuscitative measures were executed (details not provided), and the patient received intravenous epinephrine (dosage not provided) during the code. Emergency medical services transported the patient to the hospital, where he expired (details not provided). The hdrn stated the cause of death was cardiac arrest, and confirmed the patient had a past medical history including cardiovascular disease. The esrd death notification was unavailable during the call. The hdrn stated the 2008t machine did not alarm during hd therapy, and was inspected by a technician and passed all functional compliance testing. Additional information, treatment records and medical records were requested but not provided.

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). The user facility reported the machine was inspected by a technician and passed all functional compliance testing. 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: 2008T HEMODIALYSIS SYSTEM WITHOUT 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: 8136863
• MDR Text Key: 129443854
• Report Number: 2937457-2018-03590
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K113427
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 12/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 190858
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 12/20/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/27/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse

Patient Treatment Data

Date Received: 12/06/2018 Patient Sequence Number: 1