MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SSPECTRA OPTIA IDL SET

Catalog Number 10310

Device Problems Partial Blockage (1065); Occlusion Within Device (1423); Device Displays Incorrect Message (2591); Device Operational Issue (2914)

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

Event Date 03/08/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation: per the customer, the spectra optia machine displayed that 499ml of acdawas used during the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that approximately 2 hours into a collection procedure, they received multiple high pressure alarms.The operator observed clotting in the collection bag and in there-infusion tubing line.The operator stopped and aborted the procedure.It is unknown at this time if medical intervention was required for this event.Patient information and outcome are not available at this time.Terumo bct is awaiting return of the collection set for investigation.

Manufacturer Narrative

Investigation: per the customer, the spectra optia machine displayed that 499ml of acda was used during the procedure.However, the acda was completely full.The optia set was received for evaluation.Visual inspection confirmed the set was assembled correctly with no kinks, leaks, occlusions or missing parts.Flow of blood was observed throughout the set and in the inlet line, cassette and channel.There was evidence of clumping in the channel connector.No disposable defects were identified.The run data file (rdf) was analyzed for this event.Review of the rdf and aim interface images for this procedure confirmed the presence of clumping in the connector throughout the entirety of the procedure.The procedure was eventually ended because the clumping led to ¿return pressure was too high¿ alarms after 109 minutes.According to the complaint little to no ac was actually removed from the bag.This may indicate that there may have been a blockage or occlusion in the ac line.Possible causes for this include the ac line becoming occluded as a result of loading into the ac fluid detector or by some component near the ac line such as a blood warmer or a defect in the tuning set.An occlusion in the ac line could have caused fluid to be consistently present at the ac fluid detector, while limiting/blocking flow through the ac line at the same time.The signals in the run data file 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.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.Investigation is in process.A follow-up report will be provided.

Event Description

Patient's gender and weight were obtained from the run data file (rdf).

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.Root cause: review of the rdf and aim interface images for this procedure confirmed the presence of clumping in the connector throughout the entirety of the procedure.The procedure was eventually ended because the clumping led to ¿return pressure was too high¿ alarms after 109 minutes.According to the complaint little to no ac was actually removed from the bag.This may indicate that there may have been a blockage or occlusion in the ac line.Possible causes for this include the ac line becoming occluded as a result of loading into the ac fluid detector or by mono component near the ac line such as a blood warmer or a defect in the tubing set.An occlusion in the ac line could have caused fluid to be consistently present at the ac fluid detector, while limiting/blocking flow through the ac line at the same time.

Manufacturer Narrative

This report is being filed to provide additonal information.The customer stated that medical diagnostics was given to thepatient and test results indicated that there was no clotting activation within the patient.

Event Description

Due to (b)(6) personal data protection laws, the patient information is not available from thecustomer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SSPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10810 w. collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6473219
• MDR Text Key: 72501635
• Report Number: 1722028-2017-00137
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• 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,Followup
• Report Date: 04/07/2017

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: 10310
• Device Lot Number: 10Z3119
• Other Device ID Number: 05020583103108
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2017
• Initial Date FDA Received: 04/07/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided; Not provided
• Supplement Dates FDA Received: 05/02/2017; 06/16/2017; 06/22/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/19/2016
• 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: 78