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

Catalog Number 000000000000010110

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Venipuncture (2129)

Event Date 01/20/2015

Event Type  malfunction  

Event Description

The customer reported that after a csp sampling for an autologous graft, they noticed the yield from a csp sampling was well below the expected result.The donor had to undergo another collection procedure.Patient outcome is not available at this time.Due to eu personal data protection laws, the patient information is not available from the customer.Donor gender and weight were obtained from the run files.The disposable kit is not available for return because it was discarded by the customer.This report is being filed in response to the customer filing a sae report with their local authorities.

Manufacturer Narrative

Investigation: per the customer, the donor's pre-procedure complete blood count (cdc) and the yield estimated by the spectra optia machine, indicated that only one collection would have been necessary.The run data file was analyzed for this event.Signals in the data file do not indicate a conclusive root cause for the low collection efficiency reported for this procedure.The patient had higher wbc counts and there were portions of the procedure in which a buffy coat did accumulate.The operator did take the appropriate action by lowering the collection preference early on in the procedure.Later in the procedure the operator received multiple ¿interface took too long to establish¿ alarms.The operator lowered the hct from 36% to 34%.This seemed to resolve the issue shortly after receiving another alarm.The operator also received the ¿chamber took too long to fill¿ alarm.This too can suggest that a buffy coat is building up.If the patient has a wbc count >30, there may be too few red cells in the chamber for the rbc detector to detect in order to initiate chamber collections.If the patient has a high wbc and platelet count, a buffy coat may accumulate.Target cells may not get collected into chamber if a buffy coat is accumulating.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation:the customer did not provide the lot number pertaining to this event,therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.The machine was checked out at the customer site by a terumo bct technician with no issues found.Root cause: this disposable set was unavailable for specific root cause analysis.Signals in the dlog do not indicate a conclusive root cause for the low collection efficiency reported for this procedure.Possible root causes were provided in the initial report for this event.

Event Description

Due to eu personal data protection laws, patient's condition is not available.

Manufacturer Narrative

This record was identified during a retrospective review of mdrs to identify records in which an event occurred, but the type of reportable event was not indicated appropriately.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4532403
• MDR Text Key: 18261487
• Report Number: 1722028-2015-00057
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• PMA/PMN Number: K071079
• 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: 01/29/2015

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 Catalogue Number: 000000000000010110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/05/2015
• Initial Date FDA Received: 02/20/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/16/2015; 07/29/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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 Weight: 82