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

Catalog Number 10310

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

Patient Problem Hypervolemia (2664)

Event Date 12/14/2022

Event Type  malfunction  

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure on a spectra optia device, the saline line continued to drip.The operator had placed a hemostat below the drip chamber.Terumo bct support asked the operator to check the roller clamps and the red roller clamp was still open.It was reported that about 600 mls of normal saline (ns) that went to the patient.Per calculations the final fluid balance = 146.7 % patient age, weight and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation: final adjusted fluid balance = (1741 ml + 600 ml +5017 ml) / 5017 ml x 100% = 146.7 % investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: final adjusted fluid balance = (1741 ml + 600 ml +5017 ml) / 5017 ml x 100% = 146.7 % the device history records (dhr) were reviewed for this lot.  there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues (mis-clamping user errors) on this lot worldwide.Root cause: based on the information provided, the cause for the unintended saline bolus was an operator error in which the red (inlet) saline roller clamp was inadvertently left open.

Event Description

The customer reported that during a continuous mononuclear cell (cmnc) collection procedure on a spectra optia device, the saline line continued to drip.The operator had placed a hemostat below the drip chamber.Terumo bct support asked the operator to check the roller clamps and the red roller clamp was still open.It was reported that about 600 mls of normal saline (ns) that went to the patient.Per calculations the final fluid balance = 146.7 % patient age and outcome are not available at this time.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: 18988848
• MDR Text Key: 338752326
• Report Number: 1722028-2024-00104
• Device Sequence Number: 1
• Product Code: LKN
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/27/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 10310
• Device Lot Number: 2209063130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2022
• 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: 84 KG