MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW; ENFLOW¿ IV FLUID/BLOOD WARMER MODEL 100

Model Number	980105VS
Medical Device Problem Code	Insufficient Heating (1287)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/13/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
At this time, vyaire has not received the suspect device for evaluation.Any additional information received from the customer or through vyaire's internal investigation will be included in a follow-up report.
Event or Problem Description
The customer reported while using the enflow iv fluid/blood warmer model 100; the device is not warming or delivering desired temperature as intended.The issue occurred during patient-use; the patient was warmed with one machine in pre op - temperature was 36.6.The customer reported the patient received warmed fluid in the operating room - temperature was 35.5 in the middle and end of the surgery.The customer reported the temperature in the or were taken with a disposable gas machine probe and the fluid was warm to the touch that was infused into the patient in the or.(the iv tube was touched by staff).The customer reported entire system is available to be returned for analysis (controller/power supply and blood warmer in order to diagnose which part is malfunctioning).The customer reported there is no known impact or consequence to the patient at this time.
Additional Manufacturer Narrative
Results of investigation: the suspect component was returned for evaluation.Based on the evaluation the reported defect could not be traced or reproduced.

• Brand Name: ENFLOW
• Common Device Name: ENFLOW¿ IV FLUID/BLOOD WARMER MODEL 100
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8461330
• Report Number: 3008959444-2019-00008
• Device Sequence Number: 11449654
• Product Code: LGZ
• UDI-Device Identifier: 10885403296789
• UDI-Public: (01)10885403296789
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/08/2019

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: 980105VS
• Device Catalogue Number: 980105VS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/15/2019
• Initial Date Received by Manufacturer: 03/13/2019
• Supplement Date Received by Manufacturer: 05/08/2019
• Initial Report FDA Received Date: 03/28/2019
• Supplement Report FDA Received Date: 05/10/2019
• 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: Other