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); Obstruction of Flow (2423)

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

Event Date 08/13/2019

Event Type  Injury  

Manufacturer Narrative

Investigation: this event was reported when a tbct representative sent a reminder to the customer site that when implementing the new acd-a bags, it is important the nurses follow the instructions on the quick reference guide, particularly step number 2.The frangible needs to be fully broken to ensure the acd-a flows freely by bend it back and forth 4 times.This needs to be completed each time an acd-a bag is connected.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported that during a collection procedure on a patient with multiple myeloma,the frangible was not properly broken on the second bag of acda and approximately an hour later, it was noted that the product clotted.Upon recognizing the clotting, the rn inspected the optia device and noted that the inlet line was still pulling, but only pushing what product was left in the line up into the bag and the line was full of air.There was no alarms reported.Per the customer, the product was not used, an additional day of collection and mozobil/neupogen was required and the collection target was achieved on the second day.The mozobil/neupogen was part of the same protocol, however, the additional mobilization was not planned.The customer reported that the patient is stable and pending transplant.Full patient id: (b)(6).The platelet collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Corrective action: an internal capa has been initiated to evaluate the failure associated due to correct connect not been broken on 2nd bag of acda causing clotting.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.

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.Correction: on (b)(6) 2019, a terumo bct customer representative reminded thepatientsafety and quality improvement coordinator for the customer of the following: if the frangible isnot broken with the first bag of acd-a added (i.E.During machine prime), the system will alarmindicating that ac is not flowing.For subsequent bags, there is not an ac specific alarm if thefrangible was not broken since the line typically contains fluid.Additionally, the customer was informed on (b)(6) 2019, by the same terumo bct customerrepresentative, of the following: when implementing the new acd-a bags, it is important thenurses follow the instructions on the quick reference guide attached, particularly step number 2.The frangible needs to be fully broken to ensure the acd-a flows freely suggesting that theybend it back and forth 4 times (i.E.North-south-east-west) to be sure.This needs to be doneeach and every time an acd-a bag is connected.An internal capa has been initiated to evaluate the failure associated due to correct connect notbeen broken on 2nd bag of acda causing clotting.Investigation is in process.A follow-up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 8969629
• MDR Text Key: 156759781
• Report Number: 1722028-2019-00252
• 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
• 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: 04/01/2021
• Device Catalogue Number: 12320
• Device Lot Number: 1904093130
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 08/15/2019
• Initial Date FDA Received: 09/06/2019
• Supplement Dates Manufacturer Received: 09/30/2019; 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: 00063 YR
• Patient Weight: 105