MAUDE Adverse Event Report: TERUMO BCT INC. SPECTRA IDL SET; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC

Model Number SPECTRA IDL SET

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Insufficient Information (4580)

Event Date 08/27/2020

Event Type  malfunction  

Event Description

Plasma pump alarmed during procedure a cellular therapy collection procedure.Plasma pump tubing over torqued.Fluid noted when device door was opened.Procedure was halted under the guidance of the md and juno due to possible cellular therapy product (ctp) contamination.The whole blood processed was 2.948 liters with a collected ctp volume of 30 ml.No rinseback was performed.The optia spectra kit lot # 20044036.Device # 6 (serial#: (b)(4)).Fda safety report id# (b)(4).

• Brand Name: SPECTRA IDL SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA, THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT INC. ; lakewood CO 80215
• MDR Report Key: 10605937
• MDR Text Key: 209458428
• Report Number: MW5096954
• Device Sequence Number: 1
• Product Code: LKN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2022
• Device Model Number: SPECTRA IDL SET
• Device Catalogue Number: 12320
• Device Lot Number: 20044035
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 79 YR
• Patient Weight: 80