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 Problems Edema (1820); Headache (1880); High Blood Pressure/ Hypertension (1908)

Event Date 12/01/2017

Event Type  Injury  

Manufacturer Narrative

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

Event Description

A medical professional (md) reported that when the reverse osmosis (r.O) machine for one of their hemodialysis (hd) patient needed maintenance and was replaced, the patient immediately began having a bad taste in his mouth, headache, became hypertensive, and reported having an edema during treatment.Upon follow up, the md stated that some symptoms (unspecified) went away after the patient stopped using saline flushes during treatment; however the patient symptoms of headache and bad taste still persisted.Per md the hose that connects the r.O machine to the 2008k@ home machine was replaced again and the symptoms returned.The patient is now performing in-center hemodialysis (hd) with no further issues.Per md the cause of patient symptoms is unknown.Additional information regarding patient treatment records, patient demographics, machine information, r.O information was requested; however, not provided.

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 serial number of the cycler used 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.Clinical investigation: there is a temporal relationship between the patient symptoms of bad taste in the mouth, headache, hypertension and edema and hd therapy with the fresenius 2008k@home machine which is connected to the reverse osmosis machine.The patient began having symptoms appear after first use of the ro machine and again with replacement of the hose connecting the ro machine to the 2008k@home machine.There is no documentation to show a causal relationship between the patient adverse event and the 2008k@home machine.Per the reporting doctor, no cause could be determined for the patient symptoms.Eliminating saline flushes temporarily relieved some of the symptoms, but they returned with use of a new hose.Based on available information it cannot be determined what caused the adverse event.

• Brand Name: 2008K@HOME MACHINE
• Type of Device: HEMODIALYSIS SYSTEM FOR HOME USE
• Manufacturer (Section D): CONCORD MANUFACTURING; 4040 nelson avenue; concord CA 94520
• MDR Report Key: 7512679
• MDR Text Key: 108225279
• Report Number: 2937457-2018-01337
• 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: health professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1