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

Catalog Number 10220

Device Problem Connection Problem (2900)

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

Event Date 12/10/2018

Event Type  malfunction  

Event Description

On the exchange set, there is mesh that covers part of the centrifuge tubes, the mesh was not connected as normal yielding a possible weak point in the system.

• Brand Name: SPECTRA OPTIA COLLECTION SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave; lakewood CO 80215
• MDR Report Key: 8270090
• MDR Text Key: 133842250
• Report Number: 8270090
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: (01)05020583102200
• 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: 12/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Device Lot Number: 1810193430
• 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: 12/19/2018
• Event Location: Hospital
• Date Report to Manufacturer: 01/23/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/23/2019
• Type of Device Usage: N
• Patient Sequence Number: 1