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

Model Number 980200EU

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/22/2018

Event Type  malfunction  

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 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
• Type of Device: ENFLOW DISPOSABLE IV FLUID/BLOOD WARMER CARTRIDGE MODEL 200
• Manufacturer (Section D): VYAIRE MEDICAL, INC.; 22745 savi ranch parkway; yorba linda CA 92887
• Manufacturer (Section G): HEALTHCARE TECHNOLOGY INTERNATIONAL LTD.; 15/f block b, veristrong; indusry ctr 36 au pui wan st; fotan, ; HK
• Manufacturer Contact: stanley tan ; 22745 savi ranch pkwy; yorba linda, CA 92887 ; 7149193324
• MDR Report Key: 8422154
• MDR Text Key: 139111359
• Report Number: 2050001-2019-00018
• Device Sequence Number: 1
• Product Code: LGZ
• UDI-Device Identifier: 10885403286155
• UDI-Public: (01)10885403286155
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K130867
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,study
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 980200EU
• Device Catalogue Number: 980200EU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/11/2019
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Unknown
• Removal/Correction Number: 3008959444-3/13/19-001-R
• Patient Sequence Number: 1