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

Model Number 12320

Device Problems Use of Device Problem (1670); Expiration Date Error (2528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/01/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Event Description

Rejected by (b)(6).The customer reported use of an expired set during a white blood cell depletion (wbcd) procedure.The patient expired a week after the procedure.He had a poor prognosis at the time of the procedure.Customer is not claiming any issue with the system or the set other than the expiration date.Date of procedure was (b)(6) 2021 and the set expired on 04/01/2021.The collection set is not available for return because it was discarded by the customer.Patient age is not available at this time.Further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.

Manufacturer Narrative

This report is being filed to provide additional information b.5, h.6 and h.10.Corrected information is provided in b.5.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process.A follow-up report will be provided.

Event Description

This report includes information pertaining to a patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Patient age was not provided by the customer.The statement "further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information." sent in the intial mdr is not relevant to this event and has been removed from the investigation.

Manufacturer Narrative

The terumo bct clinical specialist contacted the customer regrading the importance of not using expired sets.The retaining was carried out on (b)(6) 2021.Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.Investigation is in process.A follow-up report will be provided.

Event Description

The customer reported use of an expired set during a white blood cell depletion (wbcd) procedure.The patient expired a week after the procedure.He had a poor prognosis at the time of the procedure.Customer is not claiming any issue with the system or the set other than the expiration date.Date of procedure was 04/30/2021 and the set expired on 04/01/2021.The collection set is not available for return because it was discarded by the customer.Patient age is not available at this time.

Event Description

The customer reported use of an expired set during a white blood cell depletion (wbcd) procedure.The patient, with a presenting diagnosis of acute myeloid leukemia (aml) expired a week after the procedure.He had a poor prognosis at the time of the procedure.The customer is not claiming anything wrong with the system or the kit other than the expiration date.Date of procedure was 04/30/2021 and the set expired on 04/01/2021.The collection set is not available for return because it was discarded by the customer.This report includes information pertaining to a patient death, although per current information there is no detectable malfunction with the terumo bct device or allegation of a malfunction.Patient age was not provided by the customer.

Manufacturer Narrative

Investigation: a disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Correction: the terumo bct clinical specialist contacted the customer regrading the importance of not using expired sets.The retaining was carried out on may 26th 2021.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be operator error due to the customer's unintentional use of an expired set.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
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hidlen ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 12010553
• MDR Text Key: 261944999
• Report Number: 1722028-2021-00219
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 06/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Device Lot Number: 1904093130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/08/2019
• 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 Sex: Male
• Patient Weight: 85 KG