MAUDE Adverse Event Report: QUALITY IN FLOW LTD. WARRIOR BLOOD AND FLUID WARMER; WARRIOR, QIF-01 BASE UNIT

Model Number	QIF-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
The user provided the following description: they used the unit for warming blood.The unit worked well for ~5 minutes.Then they noticed blood was leaking from the connector of the disposable unit and it felt too hot.No alert was provided by the unit.No smell of smoke / burn.They immediately cut the warming.

• Brand Name: WARRIOR BLOOD AND FLUID WARMER
• Common Device Name: WARRIOR, QIF-01 BASE UNIT
• Manufacturer (Section D): QUALITY IN FLOW LTD.; 11 haavoda st.; rosh ha'ayin, 48017 61; IS 4801761
• MDR Report Key: 8540249
• Report Number: 3013429468-2019-00002
• Device Sequence Number: 360877
• Product Code: BSB
• UDI-Device Identifier: 07290016740011
• UDI-Public: 07290016740011
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K171215
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QIF-01
• Device Catalogue Number: QPORT1100U
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/07/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2019
• Initial Report FDA Received Date: 04/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1