MAUDE Adverse Event Report: TERUMO BCT COBE 2991; SHIPPING ASSY, 2991 ENGLISH 115V

Model Number 912991000

Device Problems Defective Component (2292); Material Deformation (2976); Protective Measures Problem (3015)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 11/05/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation: the service technician was able to spin the centrifuge with the covers open.Replacing the solenoid interlock assembly did not resolve the issue.After speaking with a terumo bct technical support specialist, the service representative replaced the pump relay cca.Following replacement of the pump relay cca, pm was completed and all tests passed.The machine was ready for use.Performed annual pm per mfr specifications without error.All test passed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

During preventive maintenance (pm) on the cobe 2991 device by a terumo bct service technician, it was found that the 'ready' light was on when the top covers were open and the centrifuge was spinning.Patient (tbct technician) age, gender and weight are not available at this time.No injury or medical intervention were reported for this event.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the device serial number history report indicates no further related issues have been reported for this device.Corrected investigation: device history report: one year of service history was reviewed for this device with no problems identified related to the reported condition.Investigation is in process.A follow-up report will be provided.

Event Description

The 2991 cell processor is meant for cell concentration and washing.No patient or donor is connected to this device.The patient identified in this event is the tbct technician present during the event.

Manufacturer Narrative

This report is being filed to provide additional information in a.3, a.4, b.5, h.6 and h.10.Investigation: the customer and the service representative did not report any injuries as a result of the failure identified during preventive maintenance.Root cause: since the replacement of the pump relay cca and solenoid interlock assembly have resolved the issue, it is likely that these parts were defective or a contributing factor.

Event Description

The technician declined to provide patient age.

• Brand Name: COBE 2991
• Type of Device: SHIPPING ASSY, 2991 ENGLISH 115V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 9467000
• MDR Text Key: 187103283
• Report Number: 1722028-2019-00411
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• PMA/PMN Number: K893962
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 912991000
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/25/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 66