MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K@HOME MACHINE; HEMODIALYSIS SYSTEM FOR HOME USE

Catalog Number UNKNOWN-2008K@HOME MACHINE

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

Patient Problem Death (1802)

Event Date 04/01/2018

Event Type  Death  

Manufacturer Narrative

The plant investigation is in process.A supplemental mdr will be submitted upon completion of this activity.

Event Description

This is a report of a hemodialysis patient who expired.A patient letter envelope regarding a software upgrade letter was received indicating that the patient passed away.No further information is available at this time.Should additional information become available, the file will be reassessed and updated accordingly.

Manufacturer Narrative

Plant investigation: the actual device was not returned to the manufacturer for physical evaluation.Furthermore, an investigation of the device manufacturing records was not able to be conducted by the manufacturer as the product serial number of the device was unknown, therefore an investigation of the device manufacturing records was unable to be conducted by the manufacturer.However; a device is not released if it does not meet requirements or is nonconforming.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 2008K@HOME MACHINE
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• 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: 7507145
• MDR Text Key: 108003639
• Report Number: 2937457-2018-01318
• Device Sequence Number: 1
• Product Code: ONW
• Combination Product (y/n): N
• PMA/PMN Number: K070049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial,Followup
• Report Date: 05/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2018
• Is this an Adverse Event Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN-2008K@HOME MACHINE
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 05/16/2018
• 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