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

Model Number 61000

Device Problem Component Falling (1105)

Patient Problem No Patient Involvement (2645)

Event Date 03/06/2018

Event Type  malfunction  

Manufacturer Narrative

Mechanical evaluation investigation: a service call was placed and a service technician checked out the device at the customer site.The service technician was able to duplicate the reported condition.Upon visual inspection, a loose set of screw was observed.The loose set screw was tightened on the iv pole and the machine was returned to service.One year of service history was reviewed for this device with no other problems identified related to the reported condition.The device serial number history report indicated no further related issues have been reported for this device.Root cause: the root cause of the failure was a loose set screw on the iv pole.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.

Event Description

The customer reported that while removing the blood warmer tubing line from the iv pole, she noticed the iv pole unexpectedly lowers down and does not stay in the 'up' position.No injury was reported for this incident and no patient was connected at the time the iv pole was unexpectedly lowering down, therefore no patient information is reasonably known.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 7386608
• MDR Text Key: 104265850
• Report Number: 1722028-2018-00083
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071079
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/30/2018

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: Health Professional
• Device Model Number: 61000
• Other Device ID Number: 05020583610002
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/06/2018
• Initial Date FDA Received: 03/30/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other