MAUDE Adverse Event Report: STIHLER ELECTRONIC GMBH PRISMAFLO II S; ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS

Model Number PF2300NA

Device Problem Fire (1245)

Patient Problem Insufficient Information (4580)

Event Date 07/17/2020

Event Type  malfunction  

Event Description

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 II S
• Type of Device: ACCESSORIES, BLOOD CIRCUIT, HEMODIALYSIS
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; 12011 mosteller road; cincinnati OH 45241
• MDR Report Key: 10527504
• MDR Text Key: 206731138
• Report Number: 10527504
• Device Sequence Number: 1
• Product Code: KOC
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: PF2300NA
• Device Catalogue Number: PF2300NA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/20/2020
• Device Age: 7 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5110 DA