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

Model Number PF2-2618

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Further investigations are not possible as the defective heating profile, affected sheets and reports of periodical maintenance were not available for investigation.Should additional relevant information become available, a supplement report will be submitted.There was no patient injury or medical intervention associated with this event.

Event Description

During recirculation mode using a blood warmer, prismaflo ii was smoking and actively burning hole through sheets of bed.The nurse noticed a burning smell in the room.Treatment was discontinued.There was no report of patient injury or a medical intervention associated with this event.

• Brand Name: PRISMAFLO II
• Type of Device: BLOOD WARMER
• Manufacturer (Section D): STIHLER ELECTRONIC GMBH; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• Manufacturer (Section G): STIHLER ELECTRONIC GMBH; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• Manufacturer Contact: michael schelling ; julius-hoelder-strasse 36; stuttgart, 70597 ; GM 70597
• MDR Report Key: 8342364
• MDR Text Key: 136588980
• Report Number: 9617473-2018-00010
• 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
• Remedial Action: Replace
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: PF2-2618
• Device Catalogue Number: PF2-2618
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/31/2018
• Initial Date FDA Received: 02/15/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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