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

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/10/2018

Event Type  malfunction  

Event Description

(b)(6).On (b)(6) 2018, i went to donate plasma at the above center.I have donated for years and had recently switched from csl plasma to biomat.The man who set up my machine and stuck me with the needle may need remedial training.He seems to have a little trouble sticking me.Once the donation started, he noticed that it was slow, so he readjusted the needle.On the second draw he noticed blood in the plasma receptacle.He said it was the machine and i was deferred from donating for 8 weeks.I never had a problem like this before.Either the machine was set up wrong, broken or he stuck me wrong either way.I think they need a review as to their business practices.If it was improper maintenance on their machine then it has caused me to lose a portion of my income for 2 months.

• Brand Name: PLASMA MACHINE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL DIAGNOSTIC
• MDR Report Key: 7681333
• MDR Text Key: 113933883
• Report Number: MW5078348
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 48 YR
• Patient Weight: 102