MAUDE Adverse Event Report: TERUMO BCT COBE 2991; SHIPPING ASSY, 2991 GERMAN 230V

Model Number 91004

Device Problems Fire (1245); Fluid/Blood Leak (1250); Moisture Damage (1405); Defective Component (2292); Device Displays Incorrect Message (2591)

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

Event Date 08/16/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: terumo bct's service representative stated that after the fire was extinguished, he visually inspected the machine.Upon visual inspection, no fuse were dropped and no visible damage was observed on the transformer.Investigation is in process.A follow-up report will be provided.

Event Description

The customer requested a service call to check out their cobe 2991 machine due to observing liquid in the centrifuge.A terumo bct service representative visited the customer's site and performed machine checkout.Upon visual inspection, he observed a leakage at the centrifuge plate.The machine was turned in the 'off' position and the centrifuge plate was repaired.As the machine was turned in the 'on' position for approximately 30 minutes, he noticed that the transformer on the cobe 2991 was on fire.The service representative immediately turned the machine in 'off' position and the customer extinguished the fire.It is unknown at this time if the service representative required medical intervention for this event.Terumo bct's service representative (patient) age, gender, and weight are not available atthis time.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the machine was returned for evaluation.During inspection, a service technician evaluated the machine and determined that the only defective component was the transformer.The transformer was removed and replaced.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: the machine was returned for evaluation.During inspection, a service technician evaluated the machine and determined that the only defective component was the transformer.The transformer was removed and replaced.Terumo bct is awaiting return of the defective transformer for evaluation.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information in pt identifier.Investigation: the transformer was returned for evaluation and terumo bct's technical specialist was able to duplicate the reported condition.Heat dis-infection was performed on the transformer and the transformer was visually inspected.Upon visual inspection, it was noted that the insulation on secondary of transformer (tb2) burned and peeled off, insulation of wires from tb2-3 and tb2-4 was discolored which indicated that a very high current went through these wires.It was also noted that the wire from tb2-3 of transformer goes to terminal tb1-1(machine for ground) and wire from tb2-4 of transformer goes to tb1-2 (machine for 115vac).The reported event may have occured due to a short between ground and 115 v at terminal tb1 on machine.Dmm measurements was performed and the measurements did not indicate any open winding inside of the transformer, however, could of been degraded due to this issue.One year of service history was reviewed for this device with no problems identified related to the reported condition.An internal report indicates no further related issues have been reported for this device.Root cause:the root cause of this failure was transformer that was damaged potentially due to a short of high voltage to ground.

Event Description

No injury was reported for this incident and no patient was connected at the time of the event, therefore no patient information is reasonably known.

• Brand Name: COBE 2991
• Type of Device: SHIPPING ASSY, 2991 GERMAN 230V
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6853390
• MDR Text Key: 85922535
• Report Number: 1722028-2017-00371
• 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: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 91004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other