MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA WBC SET FUNCTIONALLY-CLOSED; COBE SPECTRA APHERESIS SYSTEM

Model Number 70629

Device Problem Misassembled (1398)

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

Event Date 11/24/2014

Event Type  Injury  

Event Description

Channel lines attached to the centrifuge belt of the cobe spectra white blood cell set-functionally closed were inverted.Lot # 07w15293 - expiration date: 2016/07/01.

• Brand Name: COBE SPECTRA WBC SET FUNCTIONALLY-CLOSED
• Type of Device: COBE SPECTRA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood 80215 444
• MDR Report Key: 4317438
• MDR Text Key: 5213465
• Report Number: MW5039443
• Device Sequence Number: 1
• Product Code: LKN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/03/2014

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 Expiration Date: 07/01/2016
• Device Model Number: 70629
• Device Catalogue Number: REF
• Device Lot Number: 07W15293
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/03/2014
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention