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

Catalog Number 12320

Device Problems Clumping in Device or Device Ingredient (1095); Use of Device Problem (1670)

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

Event Date 05/16/2019

Event Type  Injury  

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.The run data file (rdf) was analyzed for this event.The aim system images showed the lighting was in normal range.The aim images did not show clumping or clotting in the collect port and the channel.The signals in the rdf indicate that the spectra optia system operated as intended.Correction: the tbct representative visited the customer site and reminded all staff that were present to ensure that they fully break the frangible by bending it in 4 directions.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported clumping in the product during a continuous mononuclear cell (cmnc) collection on a spectra optia device.The customer reported that the clumping forced them to end their collection early.The nurses believe this may have been due to incompletely broken frangible's on the correct connect acd-a.The rationale for this conclusion is that when the nurse went to change the acd-a bag in response to a bag change alert, there was still significant acd-a in the connected bag.It is unknown at this time if the product was used.An unplanned, additional collection of the donor was performed to obtain usable product.The donor is reported in stable condition.The customer declined to provide donor id and age.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide updated information in mfr site and report source.

Manufacturer Narrative

This report is being filed to provide corrected information in updated root cause: based on the clinical findings and run data file analysis, the root cause forthe clumping in the product was due to inadequate anti-coagulation of the extra corporealsystem; either due to running the procedure at an inlet:ac ratio that was too high to providesufficient anticoagulation for the patient physiology, or incomplete break of the frangible on thecorrect connect for the ac bag.During a procedure in which more than a single bag of anticoagulant is needed, when the bagempties the sensor detects air and gives the prompt, "ac container is almost empty".It is likelythat when a new anticoagulant bag is used, the anticoagulant line will still contain fluid, and, if thefrangible in the correct connect is not broken or if it is incompletely broken, that is, in thepresence of low or no flow in the anticoagulant line, fluid could remain in the line and there wouldbe no alarm indicating the inadequate flow condition.

Manufacturer Narrative

This report is being filed to provide corrective action: an internal capa has been initiated to evaluate the correct connect not broken on 2nd bag of acda causing clotting.

Event Description

The customer declined to provide the gender information.Patient's gender information wasobtained from the run data file (rdf).

Manufacturer Narrative

This report is being filed to provide in root cause: based on the clinical findings and run data file analysis, a specific root cause for theclumping in the product could not be determined.Possible causes include, but are not limited to:- inadequate anti-coagulation of the extra corporeal system due to an incomplete break of thefrangible on the correct connect for the ac bag.During a procedure in which more than a single bag of anticoagulant is needed, when the bagempties the sensor detects air and gives the prompt, "ac container is almost empty".It is likelythat when a new anticoagulant bag is used, the anticoagulant line will still contain fluid, and, if thefrangible in the correct connect is not broken or if it is incompletely broken, that is, in thepresence of low or no flow in the anticoagulant line, fluid could remain in the line and there wouldbe no alarm indicating the inadequate flow condition.- running the procedure at an inlet:ac ratio that was too high to provide sufficient anticoagulationfor the patient physiology.

Manufacturer Narrative

This report is being filed to provide in investigation: the customer was provided with support documentation; quickreference guides for the correct connect apheresis connection system and correct connect luer.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8684816
• MDR Text Key: 148452560
• Report Number: 1722028-2019-00141
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1902143230
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Weight: 48