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

Catalog Number 12320

Device Problems Use of Device Problem (1670); Improper or Incorrect Procedure or Method (2017)

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

Event Date 08/05/2019

Event Type  Injury  

Manufacturer Narrative

Investigation; per the customer, an additional 12 ml citrate (total citrate in bag was 36ml) was added to the product to try to preserve the product.The lab was asked to process immediately.Product had clots and needed to be filtered and cell recovery was minimal.Investigation is in process.A follow up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection on aspectra optia device the operator did not break the frangible on the anticoagulant citratedextrose solution a(acd-a) bag.Per the customer the error was not caught in a timely fashion and the product was compromised.The operator received a return pressure too high alarm and found fibrin in the return line.The procedure was ended and due to the low cell recovery from the collected product the patient was given plerixa for and collected for an addition 3 days to meet the transplant goal.It was not part of the original mobilization regimen.Per the customer the patient was disconnected from the machine in "good condition" and did not need a transfusion despite not being given rinseback.Isbt product id: (b)(6).Collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide in investigation: a review of the device history record (dhr) for this unit showed no irregularitiesduring manufacturing that were relevant to this issue.An internal capa has been initiated to analysis user interface error when changing acda bagwhere the operator did not break or did not fully break the frangible.The customer submitted a photograph of the product bag, which showed 2 large, distinctaggregates, as well as signs of additional clumping throughout.The customer requested the following product enhancement stating:the current screen on spectra optia gives the operator 3 directions after the acd-a bag hasbeen changed:"spike ac""squeeze drip chamber""touch confirm".There needs to be a fourth step;"break frangible".The terumobct clinical specialist sent the request to terumo global product support andtraining.Thecustomer was informed that the new software version 12 does have two screens (prior to primeand during the run) where the instructions and graphic appear for a proper ac connection(including breaking the frangible) if the ac container notification is enabled.The customer wasinformed that they could contact their sales representative for this upgrade.Investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide in investigation: per the customer the non-broken frangible occurred on the second bag of acd- a.There were no issues with the first bag used in this procedure.Root cause: based on the customer's statements and clinical findings, operator error caused the reported adverse event.The failure to break of the frangible on the correct connect for the ac bag led to inadequate anti-coagulation of the extra corporeal system and clotting in the product.It is possible for this type of error to go unnoticed for a length of time, resulting in a compromised product.During a procedure in which more than a single bag of anticoagulant is needed, the system will generate an ¿ac container is almost empty¿ alarm when it calculates the bag should be empty based on the ac bag volume that is entered by the operator at the beginning of the procedure.It is likely that when a new anticoagulant bag is used, the anticoagulant line will still contain fluid, and, if the frangible in the correct connect is not broken or if it is incompletely broken, that is, in the presence of low or no flow in the anticoagulant line, fluid could remain in the line and there would be no alarm indicating the inadequate flow condition.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8969912
• MDR Text Key: 156872918
• Report Number: 1722028-2019-00254
• 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: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 09/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1905093130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/14/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/26/2019; 11/12/2019
• Supplement Dates FDA Received: 10/01/2019; 11/15/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 00033 YR
• Patient Weight: 71