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

Model Number 2877

Device Problem Material Twisted/Bent (2981)

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

Event Date 11/07/2018

Event Type  malfunction  

Event Description

Shortly after procedure had started, the machine alarmed that the centrifuge tubing was twisted and machine prompt me to disconnect patient.Unable to return blood in tubing.Drs.And pts coordinator notified.

• Brand Name: SPECTRA OPTIA COLLECTION SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w collins ave; lakewood CO 80215
• MDR Report Key: 8089189
• MDR Text Key: 127892347
• Report Number: 8089189
• 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: Risk Manager
• Type of Report: Initial
• Report Date: 11/09/2018

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: No Information
• Device Model Number: 2877
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/09/2018
• Event Location: Hospital
• Date Report to Manufacturer: 11/20/2018
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2018
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16790 DA