MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH PRISMAFLO IIS; BLOOD WARMER

Model Number PF2-WP33

Device Problems Thermal Decomposition of Device (1071); Fire (1245)

Patient Problem Insufficient Information (4580)

Event Type  malfunction  

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".

Event Description

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.

• Brand Name: PRISMAFLO IIS
• Type of Device: BLOOD WARMER
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; gaussstrasse 4; leinfelden-echterdingen, 70771 ; GM 70771
• Manufacturer (Section G): STIHLER ELECTRONIC GMBH; gaussstrasse 4; leinfelden-echterdingen, 70771 ; GM 70771
• Manufacturer Contact: jens-peter weege ; gausstrasse 4; leinfelden-echterdingen, 70771 ; GM 70771
• MDR Report Key: 10690473
• MDR Text Key: 213622575
• Report Number: 9617473-2020-00001
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• PMA/PMN Number: K082758
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PF2-WP33
• Device Catalogue Number: PF2-WP33
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/06/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1