MAUDE Adverse Event Report: UNKNOWN PLASMAPHERESIS MACHINE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Patient Problems Hemorrhage/Bleeding (1888); Nausea (1970); Tachycardia (2095); Tinnitus (2103); Dizziness (2194); Brain Injury (2219); Diaphoresis (2452); Increased Respiratory Rate (2486); Confusion/ Disorientation (2553); Increased Sensitivity (4538)

Event Date 03/21/2023

Event Type  Injury  

Event Description

Reporter called to report that he had an incident at (b)(6) on 21 mar.2023.While reporter was donating plasma, his blood was leaking from the machine which caused it to stop working (tubing was assembled incorrectly by staff).Reporter stated that there was a puddle of blood on the floor approximately 1.5 feet wide (the incident lasted about 10-15 minutes total).Upon seeing his blood on the floor, he sat up and became dizzy, confused, breathing became rapid, sweating profusely, heart rate was high, nauseous and felt like he was going to pass out.Reporter stated that he felt like he was in shock, staff immediately administered two bags of saline and he started feeling better after a while.He was told that he had a vasovagal syncope reaction from seeing his blood on the floor.The next day, he experienced tinnitus, was still dizzy, and had light sensitivity.Reporter stated that as time went on, he was still having tinnitus, dizziness (related to vision), problems concentrating, sensitivity to visual and aural stimulation (when out in public places), emotional changes and body temperature regulation issues.Reporter said that he was diagnosed with posttraumatic psychiatric disorder (ptpd) as a result of traumatic brain injury (tbi).Reporter stated that he incurred a brain injury at the plasm donation center due to lack of oxygen for an extended period of time (10-15 minutes).Reporter is now undergoing physical and occupational therapy as a result of the incident and continues to have symptoms from the incident.Reporter feels that the plasma industry needs to be looked at because these types of incidences can cause harm or injury to plasma donors and the general public as whole.

• Brand Name: PLASMAPHERESIS MACHINE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18210538
• MDR Text Key: 329248147
• Report Number: MW5148493
• 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
• Type of Report: Initial
• Report Date: 11/24/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/24/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Is the Reporter a Health Professional?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 32 YR
• Patient Sex: Male