HOME PD SYSTEM KAGUYA
Received May 25, 2018 · Event occurred May 1, 2018
Report 1416980-2018-03197 · MDR key 7545675
Device
Generic name
System, Peritoneal, Automatic Delivery
Manufacturer
Benchmark Electronics Inc.Model number
NACatalog number
T5C8500
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Dyspnea
- Dyspnea
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE SERIAL NUMBER IS UNKNOWN; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
A PERITONEAL DIALYSIS (PD) PATIENT EXPERIENCED DIFFICULTY BREATHING WHILE PERFORMING AUTOMATED PD THERAPY ON AN AMIA DEVICE. THE ISSUE OCCURRED AFTER CONNECTION TO THE DEVICE AND DURING AN UNSPECIFIED DWELL (NO FURTHER DETAIL). IT WAS REPORTED THAT THE PATIENT WAS TAKEN AWAY IN AN AMBULANCE DUE TO THE EVENT. IT WAS UNKNOWN IF THE PATIENT WAS ADMITTED TO THE HOSPITAL. TREATMENT WAS NOT REPORTED. NO FURTHER DETAIL WAS PROVIDED REGARDING THE PATIENT¿S OUTCOME. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
A DEVICE HISTORY REVIEW REVEALED NO ISSUES THAT COULD HAVE CAUSED OR CONTRIBUTED TO THE REPORTED ISSUE. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.