MAUDE Adverse Event Report: CONCORD MANUFACTURING 2008K HEMODIALYSIS MACHINE; DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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

Patient Problem Loss of consciousness (2418)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

Plant investigation: the reported complaint is not confirmed as the complaint device was not available for manufacturer evaluation, and the serial number of the suspect device was not provided.As such, 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 hemodialysis (hd) machine in question was not known.However, all device history records (dhr) are reviewed and released according to the "dhr review checklist & release procedure." p/n 500658; a device is not released if it does not meet requirements or is nonconforming.

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 towards the end of hemodialysis (hd) treatment on an unknown hd machine, the patient ¿passed out.¿ this reportedly occurred a couple of times when the patient started dialysis therapy.The patient stated that the nephrologist changed the rate the machine takes off fluid and changed the patient¿s dry weight.The patient posted this message on (b)(6) 2018.The date of the event is unknown.As the patient reported that this happened a couple of times, this submission documents the first time the event occurred on an unknown date, therefore, the date is selected as (b)(6) 2018.No further information has been made available.

• Brand Name: 2008K HEMODIALYSIS MACHINE
• 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: 7215110
• MDR Text Key: 98071900
• Report Number: 2937457-2018-00246
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K994267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Type of Report: Initial
• Report Date: 01/24/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/24/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Device Age: MO
• Date Manufacturer Received: 01/06/2018
• 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): Other