MAUDE Adverse Event Report: BAXTER (FORMERLY GAMBRO) PRIXMA FLO II; BLOOD WARMER

Lot Number GHNA02497

Device Problems Thermal Decomposition of Device (1071); Device Emits Odor (1425); Overheating of Device (1437); Smoking (1585)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/01/2018

Event Type  Injury  

Event Description

Crrt prisma pump (prisma flo ii) was in recirculation for approx 2 hrs; rn went to put pt back on the circuit when noticed a burning smell to the room.Prisma pump blood heater tubing was smoking and actively burning hole through sheets and mattress of pt's bed at the foot of the bed.Crrt machine was immediately turned off and taken out of pt's room, ensured pt was safe from harm and room free of smoke damage, fire alarm activated.Pt unharmed during event and remained in current room after pt was placed on new bed.Both crrt machine as well as bed that was damaged were quarantined.

• Brand Name: PRIXMA FLO II
• Type of Device: BLOOD WARMER
• Manufacturer (Section D): BAXTER (FORMERLY GAMBRO)
• MDR Report Key: 7168791
• MDR Text Key: 96618131
• Report Number: MW5074427
• Device Sequence Number: 1
• Product Code: MDP
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 01/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/04/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: GHNA02497
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 2 YR
• Patient Weight: 13