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

Catalog Number 12220

Device Problems Display or Visual Feedback Problem (1184); Device Operational Issue (2914)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/15/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that during the exchange procedure, they received multiple alarms since the peripheral accesses were not optimal and the spectra optia machine had difficulties establishing an interface.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that post spectra optia exchange procedure, the replacement volume of the plasma bag did not correspond to the replacement volume displayed on the spectra optia machine.Per the customer, 6 liters of plasma were replaced during the procedure, however, the spectra optia machine displayed 5 liters of plasma replacement.Per physician's order, the operator aborted the procedure.Patient information and outcome are not known at this time.The spectra optia exchange set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Review of the run data file (rdf) showed that the fluid balance was 101% and there was no imbalance of volumes exchanged.Investigation is still in process.A follow-up report will be provided.

Manufacturer Narrative

A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.Root cause: review of the rdf for this procedure indicated the discrepancy between the targeted replace volume and the actual amount of replace volume delivered was due to the operator ending the procedure early.The initial target replace volume was set to 5700 ml.Approximately 6 minutes into the run, the target replace volume was set to 6200 ml.The device was tracking appropriately to this target; however, a series of three ¿replacement fluid was not detected¿ alarms were generated approximately 2 hours and 15 minutes into the procedure and the operator proceeded to end the run after the third of these alarms.At that point, the system had only replaced 4843 ml.Therefore, the difference between the targeted replace volume and the actual replace volume was due to operator intervention.

Event Description

Due to eu personal data protection laws, the patient identifier and age are not available from the customer.Patient¿s gender and weight were obtained from the run data file (rdf).

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6344231
• MDR Text Key: 68142817
• Report Number: 1722028-2017-00042
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K153601
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/20/2017

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: 10/01/2018
• Device Catalogue Number: 12220
• Device Lot Number: 10Z3113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/26/2017
• Initial Date FDA Received: 02/20/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 03/17/2017; 04/11/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/14/2016
• 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
• Patient Weight: 93