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

Catalog Number 12220

Device Problems Sticking (1597); Improper or Incorrect Procedure or Method (2017); Obstruction of Flow (2423); Infusion or Flow Problem (2964)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 06/07/2016

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture date and expiry are not available at this time.Investigation: per the customer, the operator inadvertently forgot to break the frangible on the 2nd acda bag.The customer stated that the 1st 450ml of acda solution bag was emptied and 131mls of acda were used from the 2nd acda bag.However, the optia machine displayed that 50mlwas drawn into the machine.The rdf was analyzed for this event.Review of the rdf and associated images for this procedure confirmed the presence of clumping in the connector starting approximately 8 minutes into the procedure.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.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.Therefore, every procedure should be observed for clumping in the connector.It is also noted that the clumping worsened even further toward the end of the procedure and eventually turned into significant clotting after the second ac bag was hung.Per the local clinical specialist, the second bag of ac was a 500ml bag.The total ac used during this procedure was 899 ml; therefore, approximately 150ml of ac should have been removed from the second bag.However, the complaint description indicated that 450ml of ac were remaining in the second ac at the end of the procedure ¿ only 50ml had actually been consumed by the system.Given the development of more severe clumping after the ac bag was changed, an occlusion in the ac line after this bag change cannot be ruled out as a cause of the exacerbated clumping toward the end of the procedure.Possible causes for this include the ac line becoming partially 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 an incomplete break of the frangible on the correct connect system.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.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.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a therapeutic plasma exchange (tpe) procedure, they observed clotting in the tpe set.While the operator hung the second anti-coagulant (acda) solution bag, it was discovered that the set was clotted.The procedure was ended without rinse back.Patient outcome, identifier and age are not available at this time.Patient's gender and weight were obtained from the run data file (rdf).The tpe set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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 run data file (rdf) for this procedure confirmed the presence of clumping in the connector.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.Given the development of more severe clumping after the ac bag was changed, per the rdf signals, an occlusion in the ac line after this bag change cannot be ruled out as a cause of the exacerbated clumping toward the end of the procedure.Possible causes for this include the ac line becoming partially 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 an incomplete break of the frangible on the correct connect system.In either case, this could have caused fluid to be consistently present at the ac fluid detector, while limiting flow through the ac line at the same time.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.

Event Description

The customer declined to provide patient identifier, age, and outcome.

Manufacturer Narrative

This report is being filed to provide additional information.Correction: terumo bct national clinical manager confirmed that the operators have been re-trained by tbct staff.

Event Description

Per the customer, no medical intervention was required for this event.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: steve kern ; 10811 w collins ave; lakewood, CO 80215 ; 3032392246
• MDR Report Key: 6115217
• MDR Text Key: 60859905
• Report Number: 1722028-2016-00613
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: AU
• 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: 11/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2018
• Device Catalogue Number: 12220
• Device Lot Number: 01Z3226
• Other Device ID Number: 05020583122208
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/26/2016
• 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
• Patient Outcome(s): Other
• Patient Weight: 97