AMIA AUTOMATED PD SYSTEM
Received Jul 13, 2018 · Event occurred Jun 19, 2018
Report 1416980-2018-04303 · MDR key 7685594
Device
Generic name
System, Peritoneal, Automatic Delivery
Manufacturer
Benchmark Electronics Inc.Model number
NACatalog number
5C9320
Lot number
NA
Product problems
- Adverse Event Without Identified Device or Use Problem
- Adverse Event Without Identified Device or Use Problem
Patient
88 YR
- Dyspnea
- Dyspnea
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED AND THE LOT 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 BREATHING DIFFICULTY WHILE PERFORMING PD THERAPY WITH AN AMIA DEVICE. THE ISSUE OCCURRED DURING FILL 1 WHILE THE PATIENT WAS CONNECTED TO THE DEVICE. THE PATIENT¿S PD NURSE INSTRUCTED THE PATIENT¿S CAREGIVER TO DO A MANUAL DRAIN. BAXTER RENAL THERAPY SERVICES ASSISTED THE CAREGIVER TO END THE THERAPY. THERE WAS NO REPORT OF MEDICAL INTERVENTION. NO FURTHER DETAIL WAS PROVIDED REGARDING THE PATIENT¿S OUTCOME FROM THE EVENT. NO ADDITIONAL INFORMATION IS AVAILABLE.