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

Catalog Number 12120

Device Problems Device Alarm System (1012); Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)

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

Event Date 06/14/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that they discovered the frangible on the 2nd acda bag was not broken.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a peripheral blood stem cell (pbsc) collection procedure, they received multiple return pressure alarms.The operator noticed that the collection set, tubing lines, and collect bag were clotted.The operator stopped the procedure.The patient completed the procedure on a new pbsc collection set.It is unknown at this time if medical intervention was required for this event.Patient's weight is not available at this time.Patient outcome is not available at this time.Terumo bct is awaiting return of the pbsc collection set for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information.Investigation: 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.Review of the rdf and associated aim images for this procedure confirmed the presence of mild clumping in the collect port from the onset of the procedure.The clumping persisted at a low-level and worsened at approximately 90 minutes elapsed run time (as calculated from the time the ¿start¿ button was pressed).The ¿ac container is almost empty¿ alert was generated at 125 minutes elapsed run time and system predicted 750ml of ac was consumed at 138 minutes elapsed run time.The device was configured for 750ml ac bag volumes so the ac bag was changed at some point between these two times which agrees with customer statements.The clumping increased in severity at 150 minutes elapsed run time, which coincides with the operator¿s report that they forgot to break the frangible for the second bag of ac.These signals suggest that the initial clumping experienced during this procedure was likely related to the patient¿s individual blood physiology and inadequate anticoagulation of the extracorporeal circuit from the beginning of the run.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.It is also noted that the clumping worsened even further and eventually turned into significant clotting after the second ac bag was hung.The complaint description indicates that the operator forgot to break the frangible on the correct connect system when they changed ac bags.If the frangible is not broken at all, noac will flow into the system from that point forward.If the ac line still contains ac from the previous bag, fluid may be consistently present at the ac detector despite the flow of ac being limited.The system will not alarm because the ac detector is not detecting air.Thus, it is reasonable to assume that the lack of ac to the system after the bag switch exacerbated the clumping into clotting and ultimately resulted in ending of the procedure.The spectra optia system is designed to monitor fluid presence in the ac line using the ac fluid detector throughout the procedure.The signals in the rdf indicate that the ac fluid detector was functioning as intended, as the sensor saw fluid in the ac line during ac prime, at the beginning of the procedure, and throughout the run.Root cause: based on customer statement that they noticed the frangible for the second acda bag was not broken and the rdf analysis that supports this based on timing of alarms, the root cause for the clotting that ended the procedure was the frangible of the second bag not being fully broken to allow acda to flow.The system operated as intended.

Event Description

Patient's weight was obtained from the run data file (rdf).The spectra optia collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide additional information.

Event Description

No medical intervention was required for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECTION SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6688459
• MDR Text Key: 79289342
• Report Number: 1722028-2017-00280
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: GB
• 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: 07/05/2017

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: 12/01/2018
• Device Catalogue Number: 12120
• Device Lot Number: 12Z3314
• Other Device ID Number: 05020583121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/15/2017
• Initial Date FDA Received: 07/05/2017
• Supplement Dates Manufacturer Received: 07/17/2017; 08/02/2017
• Supplement Dates FDA Received: 07/28/2017; 08/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2016
• 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 Age: 67 YR
• Patient Weight: 93