FDA.reportPublic FDA data

MAUDE MDR 6771556

MDR report key
6771556
Report number
2937457-2017-00691
Event key
0
Event type
3
Date of event
2017-07-05
Date received
2017-08-07
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
THOMAS C. JOHNSON
Address
920 WINTER ST. WALTHAM MA 02451 US
Phone
781-781-7816
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
12008K@HOME HEMODIALYSIS SYSTEMHEMODIALYSIS SYSTEM FOR HOME USECONCORD MANUFACTURINGONW2008K@HOME190828R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12017-08-070

Event Narratives#

N

Patient 1

THE PLANT INVESTIGATION IS IN PROCESS. A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THIS ACTIVITY.

D

Patient 1

A HOME HEMODIALYSIS (HD) THERAPIES NURSE REPORTED THAT A HOME HD PATIENT IS SWITCHING TO THE NXSTAGE MACHINE DUE TO MULTIPLE ISSUES OBSERVED WHILE USING THE FRESENIUS 2008K@HOME MACHINE FOR POSITIVE CULTURE TEST RESULTS, RESULTING IN THE PATIENT HAVING BACK-UP TREATMENT AT A DIALYSIS CLINIC. THE NURSE STATED THAT THE CLINICS ARE FULL AND SOMETIMES THE PATIENT WOULD HAVE TO DRIVE OVER AN HOUR AWAY TO GET TREATMENT. THE PATIENT REPORTEDLY LIVES IN A REMOTE AREA AND WORKS FULL TIME, CAUSING INCONVENIENCE. IN ADDITION, THE PATIENT?S MEDICAL DOCTOR (MD) HAS INSTRUCTED THAT THE PATIENT COMPLETE HD TREATMENT EITHER FOUR (4) DAYS PER WEEK FOR FOUR (4) HOURS, OR THREE (3) DAYS A WEEK FOR FIVE (5) HOURS FIFTEEN (15) MINUTES ON THE 2008K@HOME MACHINE. THE MD ALLOWS FOR THE PATIENT TO RUN EXTRA TREATMENTS AS NEEDED, AS THE PATIENT HAS SEVERE LYMPHEDEMA, CURRENT WEIGHT OF APPROXIMATELY (B)(6), AND IS SHORT OF BREATH THE MAJORITY OF THE TIME AND MAY NEED ADDITIONAL FLUID REMOVAL. THE MD WOULD PREFER THAT THE PATIENT COMPLETE HD TREATMENT EVERY DAY, HOWEVER, THE PATIENT DENIES TO COMPLY WITH THESE INSTRUCTIONS. IN ADDITION, THE PATIENT HAS DIFFICULTY SITTING LONG ENOUGH TO COMPLETE A 5 HOURS 15 MINUTES HD SESSION DUE TO BACK ISSUES. THE NURSE STATED THAT THE NXSTAGE MACHINE WOULD ALLOW FOR THE PATIENT TO RUN HD TREATMENT SIX (6) DAYS PER WEEK FOR 3 HOURS. THIS SUBMISSION IS BEING FILED FOR POSITIVE CULTURE SAMPLES THAT WERE TAKEN ON (B)(6) 2017 WHERE THE COLONY COUNT AND ENDOTOXIN RESULTS WERE HIGH. NO PATIENT ADVERSE EFFECTS OR INJURIES WERE EXPERIENCED AND NO MEDICAL INTERVENTION WAS REQUIRED. THE NURSE REDREW SAMPLES ON (B)(6) 2017 AND THE ENDOTOXIN RESULTS CAME BACK NORMAL, BUT THE COLONY COUNT WAS ABOVE SPECIFICATION LIMITS. A BIOMEDICAL ENGINEER (BIOMED) PERFORMED SERVICE ON THE MACHINE. THE BIOMED REPLACED THE DIASAFE FILTER AND BLEACHED THE MACHINE. SAMPLES WERE DREW (B)(6) 2017 AND THE RESULTS WERE WITHIN SPECIFICATION LIMITS. NO PARTS ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.