PRISMAFLO IIS
Received Oct 16, 2020
Report 9617473-2020-00001 · MDR key 10690473
Device
Generic name
Blood Warmer
Manufacturer
Stihler Electronic GmbhModel number
PF2-WP33Catalog number
PF2-WP33
Product problems
- Thermal Decomposition of Device
- Fire
Patient
Not reported
- Insufficient Information
- Insufficient Information
Narrative
Additional Manufacturer Narrative
THIS INCIDENT WAS CAUSED BY USER FAULT. PICTURES (PROVIDED BY THE HEALTH CARE FACILITY), THAT THERE HAS BEEN A MISUSE OF THE DEVICE. IN THE IFU AT FOUR DIFFERENT CHAPTERS THERE ARE PLACED WARNINGS - RISK OF OVERHEATING / DO NOT COVER (NOT EVEN PARTIALLY) THE HEATING PROFILE WHILE IN USE. ADDITIONALLY ON THE BLACK SHORT HOUSING OF THE HEATING PROFILE THERE IS PLACED A RED WARNING LABEL WITH THE SYMBOL "PROHIBITION: DO NOT COVER HEATING PROFILE - RISK OF OVERHEATING".
Description of Event or Problem
IT WAS REPORTED THAT PHYSICIAN AND BEDSIDE NURSE ENTERED PATIENT'S ROOM TO DELIVER PATIENT CARE. WHEN THEY MOVED THE PILLOW ON THE BED BY THE PATIENT'S LEG, THEY OBSERVED THE BURNT AREA ON THE BED AND PILLOW. THEY POURED WATER ON THE BED TO EXTINGUISH IT. A WARMER LINE OF THE HEATER (PRISMAFLO II DEVICE) ATTACHED TO THE CVVH PRISMA FLEX MACHINE, THAT REWARMS BLOOD ON THE RETURN TO THE PATIENT, CAUSED A SMALL FIRE IN THE MATTRESS AND PILLOW. THE TUBING LINE WAS IN THE PATIENT BED AND WAS FOUND TO BE IN BETWEEN THE PILLOW AND THE MATTRESS AND BEGUN TO BURN.