MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Model Number 12220

Device Problem Incomplete or Inadequate Priming (4041)

Patient Problem Insufficient Information (4580)

Event Date 07/30/2021

Event Type  malfunction  

Event Description

Tubing malfunctioned during priming and set-up unable to be finished.We suspect the issue is with the filter associated with the anticoagulant line.This occurred on two different sets with different lot numbers.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w. collins ave; lakewood CO 80215
• MDR Report Key: 12459370
• MDR Text Key: 271010647
• Report Number: 12459370
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12220
• Device Catalogue Number: 12220
• Device Lot Number: 2105273230
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/10/2021
• Event Location: Hospital
• Date Report to Manufacturer: 09/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1