MAUDE Adverse Event Report: QUALITY IN FLOW LTD. QINFLOW BLOOD & FLUID WARMER

Model Number	QIF-01-12
Medical Device Problem Codes	Overheating of Device (1437); Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/20/2023
Type of Reportable Event	Malfunction
Event or Problem Description
At 0846 a fire alarm was activated in our pedi operating room 19.It was noted anesthesia blood warmer on iv pole was smoking and quickly turned to flames.At this point water was applied and fire extinguisher was activated.Fire was out and patient was unaffected.The system was sent to quarantine.
Additional Manufacturer Narrative
Despite multiple efforts, we were unable to replicate a similar failure scenario in our lab.Our interim conclusion is that a failure initiated in one of the hardware components, due to an abnormal extreme event and the component's performance deteriorated over prolonged operation of the system until full failure.This abnormal condition is could not be associated with any design, workmanship, or end users' actions.Following a comprehensive investigation, and based on the available data, we classified this event as a "singular event".The affected device will remain in the possession of the manufacturer for future investigation, as applicable.
Event or Problem Description
At 0846 a fire alarm was activated in our pedi operating room (b)(6).It was noted anesthesia blood warmer on iv pole was smoking and quickly turned to flames.At this point water was applied and fire extinguisher was activated.Fire was out and patient was unaffected.The system was sent to quarantine.

• Brand Name: QINFLOW BLOOD & FLUID WARMER
• Common Device Name: QINFLOW BLOOD & FLUID WARMER
• Manufacturer (Section D): QUALITY IN FLOW LTD.; 23 ha-yetsira st.; central; petah tikva, 49512 51; IS 4951251
• Manufacturer (Section G): QUALITY IN FLOW LTD.; 23 ha-yetsira st.; petah tikva, central 49512 51; IS 4951251
• Manufacturer Contact: omer pechter ; 23 ha-yetsira st.; petah tikva, central 49512-51 ; IS 4951251
• MDR Report Key: 16370734
• Report Number: 3013429468-2023-00001
• Device Sequence Number: 15142854
• Product Code: BSB
• UDI-Device Identifier: 07290016740073
• UDI-Public: 07290016740073
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K211800
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Risk Manager
• Remedial Action: Replace,Inspection
• Type of Report: Initial,Followup
• Report Date (Section B): 03/10/2023

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-01-12
• Device Catalogue Number: QPORT1100U12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/20/2023
• Supplement Date Received by Manufacturer: 01/20/2023
• Initial Report FDA Received Date: 02/14/2023
• Supplement Report FDA Received Date: 03/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/06/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown