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

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Bacterial Infection (1735)

Event Date 01/06/2023

Event Type  Injury  

Event Description

Staph infection requiring hospitalization for iv antibiotics after two rounds of plasmapheresis.

• Brand Name: PLASMAPHERESIS DEVICE
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• MDR Report Key: 16205046
• MDR Text Key: 307808756
• Report Number: MW5114386
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 01/14/2023

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: Health Professional
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention; Hospitalization
• Patient Age: 62 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White