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

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

Patient Problem Collapse (2416)

Event Date 01/01/2014

Event Type  Injury  

Manufacturer Narrative

Plant investigation: no parts were returned to the manufacturer for physical evaluation.A definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.An investigation of the device manufacturing records was not able to be conducted by the manufacturer as the serial number of the 2008k@home hemodialysis (hd) machine in question was not known.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist and release procedure." p/n 500658; a device is not released if it does not meet requirements or is nonconforming.Clinical investigation: any possibility of causality between the event of collapsing at the end of a hemodialysis (hd) treatment and the 2008k@home hd machine cannot be assessed based on the lack of information provided.Should additional information become available the possibility of causality will be re-evaluated.

Event Description

A user post on the message forum of a dialysis website reported an event experienced by the user, who is also the patient.The post stated that the patient alleges at the end of hemodialysis (hd) treatment on a fresenius 2008k@home hd machine, the patient collapsed.The patient discontinued use of the machine at some point after this and changed the machine to a different manufacturer due to this event.Based on the information, it is estimated the alleged event occurred approximately 3.5 years ago.No further information has been made available.

• 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: 6757668
• MDR Text Key: 81516440
• Report Number: 2937457-2017-00663
• 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: company representative,consum
• Type of Report: Initial
• Report Date: 08/01/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/01/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 07/11/2017
• 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): Other