MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

Model Number 61000

Device Problems Component Falling (1105); Device Displays Incorrect Message (2591); Detachment of Device or Device Component (2907); Mechanical Jam (2983)

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

Event Date 07/31/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: a terumo bct technician inspected the spectra optia unit the next day and all 4 screw columns were broken completely from the front door assembly and the screws remained in the screw columns.A preventive maintenance was conducted 2 months ago and no problems were found with the centrifuge door assembly at that time.The new front door was installed and software was updated.Calibration and an autotest were conducted and the machine passed.However during the saline run, the machine failed for unrelated reasons'.The machine has not been released for use at this time.Investigation is in progress.A follow-up report will be provided.

Event Description

The customer reported that they were performing a mononuclear cell (mnc) collection procedure, and during the third cycle the machine alarmed "centrifuge control malfunction" and the centrifuge stopped.The operator attempted to open the door and found the door was stuck (jammed).As the operator tried to open the jammed door, the door fell down.The operator managed to close the door back using tape in order to continue the procedure.The procedure was successfully completed.Patient information and condition are not available at this time.

Manufacturer Narrative

This report is being filed to provide additional information in evaluation codes, additional mfr narrative, and corrected information in device available for evaluation?.Investigation: the part was returned for evaluation.Terumo bct's lab technician performed a bleach disinfection and was able to confirm the reported condition.Upon visual inspection, it was noted that all bosses on the door were badly broken.All pem nuts were not with returned front door.An internal report shows that the machine has been in use with no further occurrences of the problem.Root cause: the root cause of this failure was a damaged centrifuge door.

Manufacturer Narrative

This report is being filed to provide additional information and corrected information.One year of service history was reviewed for this device with no problems identified related to the reported condition.

Event Description

The customer declined to provide patient identifier.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: matthew bickford ; 10810 w collins ave; lakewood, CO 80215 ; 3032052494
• MDR Report Key: 5905266
• MDR Text Key: 54053507
• Report Number: 1722028-2016-00473
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: JO
• PMA/PMN Number: BK140151
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 61000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 00034 YR
• Patient Weight: 101