MAUDE Adverse Event Report: HAEMONETICS CORPORATION PLASMA MACHINE / NEXSYS PCS; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problems Chest Pain (1776); Diarrhea (1811); Headache (1880); Pain (1994)

Event Date 07/08/2021

Event Type  Injury  

Event Description

Pain in both shins; kedplasma upped the amt of plasma they take from me from 8000 ml to 10000 ml without asking me.Also occurred (b)(6) 2021.Experienced pain in both shins, chest pains, headaches and diarrhea.Is it safe to donate 10,000 ml of plasma in a single donation ? is it safe to donate 10,000 ml of plasma twice with only one day in between? fda safety report id # (b)(4).

• Brand Name: PLASMA MACHINE / NEXSYS PCS
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): HAEMONETICS CORPORATION
• MDR Report Key: 12252844
• MDR Text Key: 264494469
• Report Number: MW5102863
• 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: 07/27/2021

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?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/29/2021
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 61 YR