MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA APHERESIS SYSTEM; SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA THERAPEUTIC

Model Number SPECTRA PTIA

Device Problems Defective Component (2292); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  Injury  

Event Description

An autologous cellular therapy (ctp) collection was performed on a (b)(6) y/o male, diagnosed with multiple myeloma.The ctp collection was performed per protocol without any issues throughout the procedure, except for a few occlusion alarms towards the last hour of the procedure which were central venous catheter related.The pt peripheral cd 34 count of 90 and a total of 16.182 liters of whole blood was processed via a triple lumen trifusion central venous catheter.Acda-a ratio used throughout the procedure was 12:1.At the end of the procedure the ctp labeling was verified for accuracy and visual inspection of the ctp was performed and authenticated by two rns.No visual abnormalities of the ctp were noted prior to distribution to the processing facility.The processing facility personnel who accepted the ctp also confirmed the visual inspection of the ctp showed no abnormalities at the time of distribution.At approx 1400, as stated by the processing facility personnel, the md was notified and he visually assessed the ctp.After close inspection of the ctp, the ctp was deemed unusable.

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL AND PLASMA THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT, INC. ; 10811 w. collins ave; lakewood CO 80215
• MDR Report Key: 9426837
• MDR Text Key: 169897027
• Report Number: MW5091508
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): Y
• 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: 10/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPECTRA PTIA
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/05/2019
• 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): Required Intervention
• Patient Age: 60 YR
• Patient Weight: 63