AMIA AUTOMATED PD SYSTEM
Received Jan 29, 2018 · Event occurred Jan 4, 2018
Report 1416980-2018-00398 · MDR key 7224652
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
65 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT A LOW PRIORITY ALARM 30166 (MAX AIR EXCEEDED) OCCURRED ON AN AMIA AUTOMATED PD SYSTEM. THIS ALARM OCCURRED DURING SETUP WHILE THE PATIENT WAS NOT CONNECTED. THERE WERE NO LEAKS, ALL BAGS APPEARED CONNECTED, AND ALL CLAMPS WERE CLOSED ON UNUSED LINES. THE RENAL THERAPY SERVICE AGENT EXPLAINED THE ALARM TO THE CARE GIVER. THE CARE GIVER ALSO STATED THAT THE PATIENT NEVER HAD THE ALARM BEFORE. THE CARE GIVER ENDED THE SET UP AND STARTED OVER WITH ALL NEW SUPPLIES. THERE WAS NO PATIENT INJURY OR MEDICAL INTERVENTION ASSOCIATED WITH THIS EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.
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.