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

Catalog Number 10110

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Information (3190)

Event Date 12/15/2013

Event Type  Injury  

Event Description

The customer reported after a full run (more than 3 hours), the optia's plasma collection was more than the amount reported on screen.This variation was found to be in excess of 12% during the quality control (product could be used after the problem detection).The customer reported that the issue occurred 50 times through out 2013 on 25 optia machines at located at several different sites.Due to eu personal data protection laws, the patient information is not available from the customer.The disposable sets are not available for return because they were discarded by the customer.This report is being filed due to insufficient information provided at this time to determine if a malfunction with the potential for death or injury occurred.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

Investigation: the disposable sets were unavailable for return and investigation.The fluid balance differences were provided by the customer.The differences in volumes ranged from 5 - 13%, which indicates that the patients' fluid balances never exceeded the 15% tbv limit.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 run data files (rdf) were analyzed for these events.The rdfs for the ten procedures with the largest difference in volume discrepancy were compared and the ratio of the lab-measured total products removed to the tbv was not greater than 13%.There were no abnormalities noted in the rdfs that would result in the reported discrepancies.There were no other over-collection trends beyond this customer's reporting.Correction: arrangements were made for a terumo bct representative to conduct a review of the customer's procedures.The process review concluded with several recommendations, however, no singular event was pointed out as the sole contributor.Root cause: the disposable sets were unavailable for specific root cause analysis.The rdf reviews of the procedures did not find any conclusive cause for the higher than expected plasma product volume reported for these collections.The process review performed by the terumo bct sales consultant did not reveal any singular cause for the higher than expected plasma product volume, however, it cannot be ruled out that a weighing or calculation error may have occurred.

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 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: kristen cohen ; 10811 w collins avenue; lakewood, CO 80215 ; 3032052870
• MDR Report Key: 3759403
• MDR Text Key: 4420916
• Report Number: 1722028-2014-00128
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• PMA/PMN Number: K831004
• 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,Followup
• Report Date: 03/21/2014

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?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10110
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/24/2014
• Initial Date FDA Received: 04/18/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 08/28/2014; 09/24/2014; 06/29/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other