AMIA AUTOMATED PD SYSTEM
Received Jul 5, 2018 · Event occurred Jun 9, 2018
Report 1416980-2018-04122 · MDR key 7664365
Device
Generic name
System, Peritoneal, Automatic Delivery
Manufacturer
Benchmark Electronics Inc.Model number
NACatalog number
5C9320
Lot number
27110103
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
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
AN AUTOMATED PERITONEAL DIALYSIS PATIENT EXPERIENCED DYSPNEA, WHICH OCCURRED DURING LAST DRAIN ON THE HOMECHOICE DEVICE. AT THE END OF THERAPY THE PATIENT REMAINED SHORT OF BREATH. THE PATIENT STARTED OVER WITH NEW SUPPLIES SO THE INITIAL DRAIN WILL REMOVE ALL THE FLUID. IT WAS NOT REPORTED IF THE PATIENT WAS HOSPITALIZED FOR THE EVENT; HOWEVER, IT WAS REPORTED THERE WAS NO MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. THE CAUSE OF THE EVENT WAS NOT REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
A BATCH REVIEW WAS CONDUCTED AND THERE WERE NO DEVIATIONS FOUND RELATED TO THIS REPORTED CONDITION DURING THE MANUFACTURE OF THIS LOT. THE DEVICE WAS NOT RECEIVED FOR EVALUATION; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.