MAUDE Adverse Event Report: QINFLOW LTD./QUALITY IN FLOW LTD. QINFLOW BLOOD & FLUID WARMER AC UNIT; WARMER, THERMAL, INFUSION FLUID

Model Number QIF-02 AC UNIT

Device Problem Fire (1245)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/18/2023

Event Type  malfunction  

Event 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.Equipment: qinflow blood & fluid warmer model qif-02 ac unit, p/n qacplus1000, s/n (b)(4), date of mfg 10/15/2019, biomed #069-49959 and biomed pm due 3/2023, disposable product: qif warmer compact disposable unit, p/n qport0500u, lot 9905229k.

• Brand Name: QINFLOW BLOOD & FLUID WARMER AC UNIT
• Type of Device: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): QINFLOW LTD./QUALITY IN FLOW LTD.
• MDR Report Key: 16224889
• MDR Text Key: 307916362
• Report Number: MW5114421
• Device Sequence Number: 2
• Product Code: LGZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/20/2023
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 01/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QIF-02 AC UNIT
• Device Catalogue Number: QACPLUS1000
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 01 YR
• Patient Sex: Prefer Not To Disclose