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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Cardiac Arrest (1762)

Event Date 02/12/2019

Event Type  Injury  

Manufacturer Narrative

The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.   clinical investigation: a temporal relationship exists between hd therapy with the 2008t hemodialysis machine and the patient¿s cardiac arrest during hd therapy on (b)(6) 2019. However, based on the information available, the 2008t hemodialysis machine can be disassociated from this event, as there is no evidence a machine deficiency or malfunction was associated with this event. Per the nurse present at the event, the event was unrelated to the functionality of the 2008t hemodialysis machine. The patient¿s reported instability was the primary causal factor in this event. Additionally, the 2008t hemodialysis machine passed all functional compliance testing following the event.

Event Description

On (b)(6) 2019 a biomedical technician called fresenius technical support to request functional compliance testing on a 2008t hemodialysis (hd) machine. The bio-medical technician reported this (b)(6)-year-old male patient with end stage renal disease (esrd) on hd for renal replacement therapy (rrt) cardiac arrested during hd therapy on (b)(6) 2019. Follow-up revealed the patient was vented, and reportedly being dialyzed without the removal of fluid due to instability. 1:45 minutes into a 2. 0-hour hd treatment, the nurse noted the patient¿s heart rate was not registering on the ventilator and called a code. The hd therapy was discontinued; however, no further details are available. The patient survived the cardiac arrest; however, remains in critical condition. During follow-up the nurse stated the patient¿s condition is not improving, and the patient can no longer tolerate hd therapy. Additional details surrounding the patient¿s hospitalization were requested; however, the request was declined. The nurse reported the cardiac arrest was unrelated to the functionality of the 2008t hd machine. The nurse stated she was just following protocol when she requested the functional compliance testing and was not expecting any findings. A fresenius regional equipment specialist (res) inspected the machine on (b)(6) 2019 confirmed the machine was performing within manufacturer specifications during the event. All functional compliance testing was passed.

• 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; director, quality systems; 4040 nelson avenue; concord CA 94520
• Manufacturer Contact: matthew amaral ; 920 winter st.; waltham, MA 02451 ; 7816999758
• MDR Report Key: 8369559
• MDR Text Key: 137119436
• Report Number: 2937457-2019-00604
• Device Sequence Number: 1
• Product Code: KDI
• 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: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 03/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Device Catalogue Number: 190713
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 03/22/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/02/2018
• 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: 02/26/2019 Patient Sequence Number: 1