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

Device Problems Inadequate or Insufficient Training (1643); Improper or Incorrect Procedure or Method (2017); Patient-Device Incompatibility (2682); Improper Flow or Infusion (2954)

Patient Problems Bruise/Contusion (1754); Infiltration into Tissue (1931); Pain (1994); Discomfort (2330)

Event Date 10/20/2021

Event Type  Injury  

Event Description

"infiltration plasma during d;" (b)(6).After the plasma had been withdrawn, and the saline return was beginning i began to feel pressure, which was increasingly uncomfortable.As some point i began to notice that the machine was beeping, and that a worker was looking up from the task she was doing but did nothing and did not alert anyone else.After a few minutes i realized that the beeping was some sort of alarm, and i was able to get the attention of a different employee.She looked at it and said oh the saline is going into your arm and not your vein.As i was about to ask about stopping it, she left to get help.Multiple people came back with her and they discussed using my other arm, to complete the process, but no one shut off the machine.Finally when all the workers but the first left and i asked her to shut off the machine, she says shut off as she press the off button.I developed a 12 inch by 12 inch bruise, and reported this side effect in person on (b)(6) 2021, a day or so later the pain became more than uncomfortable, which i still have today.Monitoring of donors is inadequate, staff appears to either not care or not trained, or both.Fda safety report id# (b)(4).

• Brand Name: PLASMA REMOVER
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• MDR Report Key: 12780623
• MDR Text Key: 280684819
• Report Number: MW5105213
• 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: 11/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Sex: Female
• Patient Weight: 95 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White