AMIA AUTOMATED PD SYSTEM
Received Nov 30, 2017 · Event occurred Nov 10, 2017
Report 1416980-2017-09456 · MDR key 7071040
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
87 YR
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
(B)(4). THE DEVICE WAS NOT RETURNED FOR EVALUATION. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.
Description of Event or Problem
IT WAS REPORTED THAT AN UNSPECIFIED LOW PRIORITY (AIR EXCEEDED) ALARM OCCURRED ON AN AMIA AUTOMATED PD SYSTEM DURING CYCLE 5 OF PERITONEAL DIALYSIS THERAPY. THE PATIENT WAS CONNECTED AT THE TIME OF THE ALARM. AFTER THE ALARM OCCURRED THE PATIENT SHUT DOWN THE DEVICE AS PROMPTED BY THE CYCLER. DURING TROUBLESHOOTING WITH THE RENAL THERAPY SERVICE AGENT (RTSA), THE PATIENT STATED THEY DID NOT SEE ANY AIR IN THE LINES WHILE THEY WERE CONNECTED, BUT DID SEE AIR BUBBLES AFTER DISCONNECTING. 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; THEREFORE, A DEVICE ANALYSIS COULD NOT BE COMPLETED. SHOULD ADDITIONAL RELEVANT INFORMATION BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.