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

Model Number 12320

Device Problems Use of Incorrect Control/Treatment Settings (1126); Use of Device Problem (1670); Device Handling Problem (3265)

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

Event Date 01/04/2022

Event Type  malfunction  

Manufacturer Narrative

Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported an issue that was found during an audit of january's collection procedures.The customer informed that for the first day of collection on a female patient with t cell lymphoma using continuous multinuclear cell collection (cmnc) the patient's gender was entered incorrectly as male.The total blood volume (tbv) from this procedure was 4525 mls, tbv on second day when correct gender was entered was 4173 mls.Both procedures had an end target of 3l wb processed.The collection on the second day was shorter as they ended early due to having achieved target for cells needed.The patient is reported as stable and outpatient.The customer declined to provide patient 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 additional information in h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Correction: this customer was aware of the mistake and reported the issue.This customer site has not called with any further issues with any procedure after this.Hence, no retraining was required.Investigation is in process, a follow-up report will be provided.

Event Description

The customer reported an issue that was found during an audit of (b)(6) collection procedures.The customer informed that for the first day of collection on a female patient with t cell lymphoma using continuous multinuclear cell collection (cmnc) the patient's gender was entered incorrectly as male.The total blood volume (tbv) from this procedure was 4525 mls, tbv on second day when correct gender was entered was 4173 mls.Both procedures had an end target of 3l wb processed.The collection on the second day was shorter as they ended early due to having achieved target for cells needed.The patient is reported as stable and outpatient.The customer declined to provide patient 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 additional information in h.6 and h.10.Investigation: the lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Correction: this customer was aware of the mistake and reported the issue.This customer site has not called with any further issues with any procedure after this.Hence, no retraining was required.Root cause: a root cause assessment was performed for this complaint.The root cause of the potential ac over infusion was determined to be due to an operator error where they entered the incorrect patient gender in the system.

Event Description

The customer reported an issue that was found during an audit of january's collection procedures.The customer informed that for the first day of collection on a female patient with t cell lymphoma using continuous multinuclear cell collection (cmnc) the patient's gender was entered incorrectly as male.The total blood volume (tbv) from this procedure was 4525 mls, tbv on second day when correct gender was entered was 4173 mls.Both procedures had an end target of 3l wb processed.The collection on the second day was shorter as they ended early due to having achieved target for cells needed.The patient is reported as stable and outpatient.The customer declined to provide patient id and age.The collection set is not available for return because it was discarded by the customer.

• 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 hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 13685898
• MDR Text Key: 289320481
• Report Number: 1722028-2022-00076
• 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
• Report Date: 03/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 12320
• Device Catalogue Number: 12320
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 74 KG