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

Catalog Number 000000000000010120

Device Problems Air Leak (1008); Device Displays Incorrect Message (2591)

Patient Problem Thrombosis (2100)

Event Date 10/07/2014

Event Type  Injury  

Event Description

The customer reported that a donor from the national marrow donor program (nmdp)underwent a mononuclear cell (mnc) collection procedure.Close to the end of the procedure,they received multiple alarms including 'patient fluid balance may be (b)(6) lower than reported' alarm and observed air bubbles in the lines.The operator checked the lines for obstructions,but didn't see any.The operator stopped the procedure without rinseback, disconnected the donor and thought she observed a small clot at the inlet line pressure sensor.It is not known atthis time if medical intervention was required for this event.Patient (donor) identifier and age are unavailable at this time.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for injury has occurred.

Manufacturer Narrative

Investigation: the customer stated that the fluid balance reported on the spectra optia system is +734 ml.The donor's tbv is 3814 ml, 1216 ml went to the donor, 157 ml plasma was collected, and 340 ml mnc were collected, which left the donor at +(b)(6) tbv.The disposable set was returned for investigation.Clots were noted in the inlet sensor reservoir.Investigation is in process.A follow-up report will be provided.

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.A review of the lot for similar reports was carried out, none have been reported.The machine was checked out at the customer site by a terumo bct technician.Autotests were performed and the machine was found to be functioning within specifications.The run data file (rdf) was analyzed for this event.Root cause: the signals in the run data file indicate that the spectra optia system operated as intended.Based on the information available from the operator, they observed a clot in the inlet line trap which would explain the 'inlet pressure sensor malfunctioned' alarm as well as the 'patient's fluid balance may be 10% lower than reported' alarm.This fluid balance alarm indicates that there was less fluid in the tubing set as was expected which could be caused by a clot in the inlet line trap because it was preventing the expected amount of fluid from entering into the tubing set.The system predicted the end of procedure fluid balance to be 119.5%, so with the 'patient's fluid balance may be 10% lower than reported' alarm, the worst case would have been that the patient's fluid balance was only 109.5%.In mnc procedures there is no prescribed or targeted fluid balance, during the procedure the system continuously monitors the fluid balance to ensure that it remains within the system configured fluid balance limits.In this particular case, the system was well within the fluid balance limits even with the 10% fluid balance alarm.

Event Description

Extra calcium was provided to the patient after the procedure.The patient was reported instable condition.

Manufacturer Narrative

Event Description

Over the counter (otc) calcium tablets were given to the patient after the procedure.No other medical intervention was necessary for this event.Patient identifier was not provided by the customer.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's to identify records in which an event occurred, but the type of reportable event was not indicated appropriately in the mdr form.This supplement is being filed to modify information to align with the reported event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: jessica kim ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314812
• MDR Report Key: 4218000
• MDR Text Key: 15999841
• Report Number: 1722028-2014-00435
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/31/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2016
• Device Catalogue Number: 000000000000010120
• Device Lot Number: 05W3228
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/28/2014
• Is the Device Single Use?: Yes
• 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: 25 YR
• Patient Weight: 64