MAUDE Adverse Event Report: VYAIRE MEDICAL, INC. ENFLOW; ENFLOW DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE MODEL 200

Model Number	980200EU
Medical Device Problem Code	Particulates (1451)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	01/22/2018
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
The university of göttingen compared aluminium uncoated enflow cartridges vs.Coated.They found high concentration of aluminium in the enflow cartridges, when using a balanced infusion of stero fund in 1/1e.The customer reported using balanced infusion with an uncoated cartridge could cause high aluminium concentrations above specification limits with a potential of an acute organ toxic incident for patient with kidney dysfunction.The customer reported the allegations were performed under bench testing and there is no patient involvement associated with this event.

• Brand Name: ENFLOW
• Common Device Name: ENFLOW DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE MODEL 200
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 8422154
• Report Number: 2050001-2019-00018
• Device Sequence Number: 11319763
• Product Code: LGZ
• UDI-Device Identifier: 10885403286155
• UDI-Public: (01)10885403286155
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K130867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,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: 980200EU
• Device Catalogue Number: 980200EU
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• 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