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

Catalog Number 12320

Device Problem Insufficient Information (3190)

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

Event Date 03/14/2024

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

Customer reported that during a continuous mononuclear cell collection (cmnc) procedure the operator observed clumping and decreased the ac ratio to 6:1.The operator stated that they could see little bubbles in the blood warmer line and that they will remove the bubbles by disconnecting the blood warmer and bleeding it out.Patient information and outcome are not known at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: the customer did however submit a photograph to aid investigation.The photo shows the cassette loaded on the optia device, with blood throughout the set.The back of the blood warmer can be seen but not the tubing in the blood warmer.Small and large air bubbles are observed in the tubing from the blood warmer, and in the return line.The reservoir is noted to be approx.Half full.No kinks or misassemblies are seen in the photo.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

Customer reported that during a continuous mononuclear cell collection (cmnc) procedure the operator observed clumping and decreased the ac ratio to 6:1.The operator stated that they could see little bubbles in the blood warmer line and that they will remove the bubbles by disconnecting the blood warmer and bleeding it out.The customer said all luer connections were tight and there were no alarms.They said there was no clotting in the channel or in the return reservoir.The customer placed a 4-way stopcock between the patient and the blood warmer tubing to withdraw air prior to reaching the patient.No medical intervention was required.The customer declined to provide the patient information.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): TEURMO 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: 19061099
• MDR Text Key: 340468366
• Report Number: 1722028-2024-00131
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583123205
• UDI-Public: 05020583123205
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• 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
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 12320
• Device Lot Number: 2306283341
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/14/2024
• Initial Date FDA Received: 04/08/2024
• Supplement Dates Manufacturer Received: 04/22/2024
• Supplement Dates FDA Received: 05/02/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/28/2023
• 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