MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Catalog Number 10310

Device Problems Use of Device Problem (1670); Device Displays Incorrect Message (2591); Inadequate User Interface (2958)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Signals in the rdf indicated that the optia system operated as intended.Investigation is in process.A follow-up report will be provided.

Event Description

The customer initially contacted terumo bct support specialist due to receiving multiple 'inlet saline line is obstructed' alarm at the beginning of a polymorphonuclear (pmn) cell collection procedure.During customer follow-up, it was confirmed that the operator inadvertently switched the saline and hetastarch bags.The hetastarch and trisodium citrate was spiked on the green saline spike and the saline was spiked on the orange anticoagulant spike.Per the customer, the error was discovered during prime before the patient (donor) was connected to the procedure.No patient (donor) was connected at the time of the vent.No patient (donor) information is reasonably known.The pmn cell collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Spectra optia operator's manual directs the operator of the proper manner and sequence to connect solutions.Root cause: based on the customer statements and the run data file analysis, the root cause of this incident is determined to be operator error.As soon as the operator noticed the error, he immediately terminated the procedure.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6011647
• MDR Text Key: 57321373
• Report Number: 1722028-2016-00554
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153601
• 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,Followup
• Report Date: 10/07/2016

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: 07/01/2018
• Device Catalogue Number: 10310
• Device Lot Number: 07Z3201
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2016
• Initial Date FDA Received: 10/07/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other