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 06/26/2019

Event Type  Injury  

Manufacturer Narrative

Clinical review; a temporal relationship exists between hd therapy utilizing the 2008t machine, and the serious adverse event of cardiac arrest. The bmt reported the 2008t machine passed all functional compliance testing following the code and was returned to service. Additionally, the bmt stated there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code. Therefore, based on the totality of the information available, the 2008t machine can be disassociated from the event as there is no allegation or objective evidence indicating a product deficiency or malfunction was associated with the event. The plant investigation is in process. A supplemental mdr will be submitted upon completion of this activity.  .

Event Description

It was reported that a patient on hemodialysis (hd) for renal replacement therapy (rrt) coded during hd therapy. Follow-up with the user facility¿s biomedical technician (bmt) confirmed the event(s) occurrence, and the sequestering of the machine following the cardiac arrest. The bmt reported the 2008t hemodialysis machine was inspected (specifics not provided) and cultures were obtained (specifics and results not provided). Reportedly, the 2008t machine passed all functional compliance testing and was returned to service. The bmt confirmed there was no allegation against the 2008t machine, and advised the machine was sequestered per the outpatient dialysis clinic¿s procedure following a code. Additional information regarding the patient and event has been requested; however to date has not been provided.

• 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: 8827526
• MDR Text Key: 152227457
• Report Number: 2937457-2019-02308
• 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: company representative,user f
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2019
• 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?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Device Age: MO
• Event Location: No Information
• Date Manufacturer Received: 07/29/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/26/2012
• 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: 07/25/2019 Patient Sequence Number: 1