MAUDE Adverse Event Report: ALYX ; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Dyspnea (1816); Fainting (1847); Tachycardia (2095); Malaise (2359)

Event Date 04/04/2019

Event Type  Injury  

Event Description

My daughter participated in a high school blood drive run by the community blood center.They asked her to do a "power donation" on the alyx machine.They had her sign a form and did not review any of the dangers of this machine.She immediately became sick and they continued to run the machine after they laid her down and put ice packs on her.She was so sick the next day she had to stay home from school and her resting heart rate was 140.I took her to the drs the next morning and they did blood work.They dropped her hemoglobin from 14.8 to 11.2 on this machine.Her wbc count was also low.She had difficulty breathing and felt faint several times.She went from being a healthy, robust athlete to now being anemic and had to stop playing soccer her senior year.I am outraged that this machine was allowed to be brought to a high school and experimented on teenagers who do not know any better.I spoke to the medical director of this company and he stated they are not concerned unless the hgb goes below 10.This is criminal to drop someone's hgb so drastically and not care how that will impact them over the next month, high school student no less.She was essentially walking around in shock the first 24 hours.How is this being allowed? fda safety report id# (b)(4).

• Brand Name: ALYX
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• MDR Report Key: 8519407
• MDR Text Key: 142261525
• Report Number: MW5085907
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient Family Member or Friend
• Type of Report: Initial
• Report Date: 04/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/15/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening
• Patient Age: 18 YR
• Patient Weight: 73