MAUDE Adverse Event Report: VYAIRE MEDICAL ENFLOW; ENFLOW 8482 DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE WITH IV EXTENSION

Model Number	980202EU
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/08/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Vyaire file identification: (b)(4).A recently conducted internal testing with the results received by vyaire medical on 11 march 2019 indicates that there is the potential to elude aluminum from the enflow disposable cartridge during intravenous warming therapy with fluid and blood solutions.As a result, vyaire is initiating an immediate global recall of the enflow disposable cartridges part number 980200eu & 980202eu.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
After being alerted to possibly high levels of aluminium being released into infusate after use of the enflow cartridge via guardian article and anaesthesia paper, (b)(6) hospital elected to conduct their own bench testing using saline and plasmalyte (baxter).Samples were collected using no-touch technique.Samples sent to a local lab (labplus) for trace element (aluminium) testing (testing protocol unknown).Based on the results they find the aluminium levels unreasonably high and are not using the enflow on any patients until a suitable alternative is found.

• Brand Name: ENFLOW
• Common Device Name: ENFLOW 8482 DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE WITH IV EXTENSION
• Manufacturer (Section D): VYAIRE MEDICAL; 22745 savi ranch pkwy; yorba linda CA 92887
• MDR Report Key: 8423025
• Report Number: 2050001-2019-00021
• Device Sequence Number: 2242028
• Product Code: LGZ
• UDI-Device Identifier: 10885403286162
• UDI-Public: (01)10885403286162
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature,study
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 03/11/2019

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: 980202EU
• Device Catalogue Number: 980202EU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2019
• Initial Report FDA Received Date: 03/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): Yes
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 3008959444-3/13/19-001-R
• Patient Sequence Number: 1