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

Catalog Number 12320

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

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

Event Date 02/29/2024

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on a spectra optia device the collect line was "clotted".The operator changed out the blood warmer tubing because there was a faulty luer connection and air was coming into the set.The operator confirmed that there was color in the collect port in the centrifuge, and that the interface was unstable.The operator lowered the ac ratio down to 8 and adjusted the cp as needed.The operator consulted a physician and continued the procedure.Per the customer, there was no evidence of clumping in the connector.Customer information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

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.Investigation is in process and a follow up report will be provided.

Event Description

The customer reported that during a continuous mononuclear cell collection (cmnc) procedure on a spectra optia device the collect line was "clotted".The operator changed out the blood warmer tubing because there was a faulty luer connection and air was coming into the set.The operator confirmed that there was color in the collect port in the centrifuge, and that the interface was unstable.The operator lowered the ac ratio down to 8 and adjusted the cp as needed.The operator consulted a physician and continued the procedure.Per the customer, there was no evidence of clumping in the connector.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.

Event Description

The customer reported that within the first few minutes of a continuous mononuclear cell collection (cmnc) procedure on a spectra optia device the collect line was "clotted".The luer lock from the blood warmer tubing was attached securely, and not cross-threaded, however the blood was leaking from that specific connection and air was potentially coming into the set.The operator confirmed that there was color in the collect port in the centrifuge, and that the interface was unstable.The operator lowered the ac ratio down to 8 and adjusted the cp as needed.The procedure was paused and the blood warmer tubing was discarded.After consultation from the physician at the customer site, another blood warmer tubing was primed with saline and reattached, the procedure was then continued.Per the customer, there was no evidence of clumping in the connector, no air visible and no clots.The patient was reported as stable.The customer declined to provide patient information.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.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.A disposable complaint history search was not performed as the customer did not provide the lot number.Root cause: a root cause assessment was performed for this complaint.The root cause of the clotting was determined to be due to the anti-coagulant ratio used in the procedure, it was inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.The root cause of the air in the set and the leak at the blood warmer tubing luer was determined to be due to a faulty blood warmer luer connection.

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• 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: 18970047
• MDR Text Key: 339037383
• Report Number: 1722028-2024-00101
• 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,Followup
• Report Date: 03/25/2024

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/29/2024
• Initial Date FDA Received: 03/25/2024
• Supplement Dates Manufacturer Received: Not provided; 04/29/2024
• Supplement Dates FDA Received: 04/19/2024; 05/10/2024
• Was Device Evaluated by Manufacturer?: No
• 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