MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW IV FLUID/BLOOD WARMER; WARMER, THERMAL, INFUSION FLUID

Model Number	ENFLOW IV FLUID/BLOOD WARMER
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2021
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Vyaire and hti, conducted an investigation and performed a test with the enflow test setup where the original issue has been observed.Controller displays "not heating", however as seen in the thermometer display, warmer is capable to warm the cartridge up to 39.2 °c.It only cannot send the temperature measurement to the controller.The warmers received in 2021 have passed functionality test with the older controller.When functional tester has been replaced with a newer one, poor connection issue was observed at hti.There is a probability of poor connection among the warmers in vyaire inventory.Poor data connection is caused by the hubbell plug inner diameter being out of nema standard specification (4.19-4.32 mm), when hubbell plug is inserted in the hubbell receptacle.This only impacts the data, not power.Vyaire medical will submit a supplemental report in accordance with 21 cfr section 803.56 if additional information becomes available.
Event or Problem Description
The customer reported that the study nurse was preparing the enflow devices (warmer, cartridge, and controller) with the trained anesthetist nurse before the surgery.When the enflow warmer with the cartridge was connected to the controller, the text "not heating" was showing on the controller's screen.Despite the text, it was stated that the warmer felt warm.The study nurse replaced the warmer, and the text did not reappear again.It happened during patient use, but no harm is associated with the incident.

• Brand Name: ENFLOW IV FLUID/BLOOD WARMER
• Common Device Name: WARMER, THERMAL, INFUSION FLUID
• Manufacturer (Section D): VYAIRE MEDICAL; 510 technology dr; irvine IL 92618
• MDR Report Key: 12478071
• Report Number: 3008959444-2021-00010
• Device Sequence Number: 3936938
• Product Code: LGZ
• UDI-Device Identifier: 10190752125780
• UDI-Public: (01)10190752125780
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: ENFLOW IV FLUID/BLOOD WARMER
• Device Catalogue Number: 980105VS
• Device Lot Number: NOT APPLICABLE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2021
• Initial Report FDA Received Date: 09/15/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention