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

Patient Problem Hematoma (1884)

Event Date 02/02/2024

Event Type  Injury  

Event Description

The caller reported regarding care plaza llc and the plasma machines used by them.The reporter mentioned that the plasma machines are old and defective.It back flows and gives out air into the patients arms and causes hematoma and other reactions and are not fda approved.Also the donors are not screened according to the standards to be followed, they allow cigarette smokers and drugs consumers to donate blood.

• Brand Name: PLASMA MACHINE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 18921984
• MDR Text Key: 338110735
• Report Number: MW5152914
• 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: Unknown
• Type of Report: Initial
• Report Date: 03/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Patient Sequence Number: 1
• Patient Outcome(s): Other