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

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

Patient Problems Syncope (1610); Fatigue (1849); Vomiting (2144); Confusion/ Disorientation (2553)

Event Type  Injury  

Event Description

After giving plasma, i returned home ate fast food, vomited, passed out not sure for how long, defecated which initially i didn't realize i had done, woke disoriented which took me awhile to realize where i was by feeling around and very tired.

• Brand Name: PLASMAFORESIS
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• MDR Report Key: 10690115
• MDR Text Key: 211898752
• Report Number: MW5097268
• Device Sequence Number: 1
• Product Code: GKT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial
• Report Date: 10/02/2020

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?: No
• Device Operator: No Information
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/15/2020
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Weight: 68