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

Catalog Number 12120

Device Problems Obstruction of Flow (2423); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 01/03/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: the customer stated that the ac frangible was not correctly broken by the operator.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a mononuclear cell (mnc) collection procedure, they observed clotting in the collection set.After the operator replaced the anticoagulant (ac)solution bag, she received several return line alarms.The operator checked the lines for obstructions and observed clots in the return tubing line, collection bag and observed a long strand of clots in the chamber.The procedure was discontinued and the patient was disconnected.Per the customer, the patient was infused with the clots.It is unknown at this time if medical intervention was required for this event.Patient information is not available at this time.Patient outcome is not available at this time.The mnc collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and associated aim interface images for this procedure confirmed the presence of clumping in the connector starting approximately 180 minutes into the procedure (as calculated from the time the ¿start¿ button was pressed).The clumping persisted at a low-level and worsened approximately 40 minutes later (at 221 minutes elapsed run time).The procedure was eventually ended because the clumping led to ¿return pressure was too high¿ and ¿air was detected in return line¿ alarms.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.Furthermore, during ac prime, the system uses the inlet pressure sensor to verify that the ac line is not initially occluded.Once the procedure is started and patient blood and ac are brought into the manifold via the inlet and ac pumps, there is no way for the optia system to differentiate between the types of fluid being brought into the cassette.Consequently, the inlet pressure sensor is no longer able to check ac fluid presence during the procedure.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.It is also noted that the operator increased the inlet: ac ratio once clumping was identified.Investigation is in process.A follow-up report will be provided.

Event Description

Due to (b)(6) personal data protection laws, the patient information is not available from the customer.Patient's gender and weight were obtained from the run data file (rdf).

Manufacturer Narrative

Root cause: based on the information provided by customer and run data file analysis, the root cause for the clots was improper anticoagulant in the set due to the frangible being partially broken when the second bag was connected.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA COLLECT SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6397297
• MDR Text Key: 69995375
• Report Number: 1722028-2017-00076
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: NL
• 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: 03/10/2017

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: 07/01/2018
• Device Catalogue Number: 12120
• Device Lot Number: 07Z3315
• Other Device ID Number: 05020583121201
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2017
• Initial Date FDA Received: 03/10/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/04/2017; 04/26/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/26/2016
• 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
• Treatment: ACD-A, LOT # 16063003
• Patient Outcome(s): Other
• Patient Weight: 65