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

Catalog Number 000000000000010110

Device Problems Excess Flow or Over-Infusion (1311); Device Displays Incorrect Message (2591)

Patient Problems Overdose (1988); Swelling (2091)

Event Date 08/28/2014

Event Type  Injury  

Event Description

The customer reported that a patient was undergoing a stem cell harvest procedure.While the operator was changing the anticoagulant (ac) bag, she noticed that the saline bag was empty.All the saline clamps were checked visually and ensured they were closed.Another 500 mls of saline was hung up.During rinseback, the machine gave 'obstruction to saline line' alarm.The operator checked and found no obstruction, instead, the second saline bag was found to be empty.The operator stated that the patient's hand looked swollen but had no signs or symptoms of cardiac or respiratory problems.The patient was given some oral diuretics for the swelling.Due to eu personal data protection laws, the patient information is not available from the customer.The patient gender and weight were obtained from the run data files of the procedure.This report is being filed due to a device malfunction that has the potential for injury, and due to medical intervention in the form of oral diuretics.

Manufacturer Narrative

Investigation: the disposable set was returned for investigation.Upon visual inspection, no defects were found.The inlet and return saline lines were flow tested with the roller clamps closed.No fluid flowed through them.The run data file (rdf) was analyzed for this event.Signals in the dlog do not point to a conclusive cause for the patient reaction and the emptying of the saline bag.It is possible that the inlet saline line clamp or the return saline line clamp was either left open or was not properly clamped off and may have caused saline to drip throughout the procedure when it was not intended to.¿interface took too long to establish¿ alarms were noted in the rdf.This alarm may also be a signal that the inlet saline line clamp was left open, and therefore lowers the channel hematocrit resulting in the alarm.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 and none have been reported.Root cause: based on the investigation of the returned set and the rdfs, the likely root cause is that the inlet saline line clamp or the return saline line clamp was either left open or not prop clamped off.

Manufacturer Narrative

This record was identified during a retrospective review of mdr's, per fda request, to identify records in which a serious injury or medical intervention occurred, but the type of reportable event was not indicated as a serious injury of the mdr form.This supplement is being filed to modify information per fda request.

• 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: 4144492
• MDR Text Key: 4771569
• Report Number: 1722028-2014-00402
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: BK130065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,foreign,health professi
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/01/2016
• Device Catalogue Number: 000000000000010110
• Device Lot Number: 03W3105
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/31/2014
• Initial Date FDA Received: 10/06/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 10/31/2014; 02/03/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2014
• 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; Required Intervention
• Patient Weight: 90