AMIA AUTOMATED PD SYSTEM
Received Nov 30, 2017 · Event occurred Nov 16, 2017
Report 1416980-2017-09462 · MDR key 7071363
Device
Generic name
System, Peritoneal, Automatic Delivery
Manufacturer
Benchmark Electronics Inc.Model number
NACatalog number
5C9320
Lot number
NA
Product problems
- Device Displays Incorrect Message
- Device Displays Incorrect Message
Patient
64 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A LOW PRIORITY 30176 (MAX AIR EXCEEDED) ALARM OCCURRED ON AN AMIA AUTOMATED PD SYSTEM DURING PERITONEAL DIALYSIS THERAPY. THE ALARM OCCURRED DURING THE INITIAL DRAIN WHILE THE PATIENT WAS CONNECTED. THE PATIENT HAD DISCONNECTED AFTER THE ALARM, AND WOULD START OVER WITH NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION PROVIDED THE DEVICE WAS NOT RETURNED; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.