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

Device Problem Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 08/19/2022

Event Type  malfunction  

Event Description

After initiation of the therapeutic plasma exchange procedure on the patient while in hospital, an alarm appeared stating the system detected cells in the plasma line from the centrifuge.The rn was unable to resolve the issue and contacted terumobct.They were not able to assist her with resolving the issue and the procedure was aborted.The attending md was contacted and another cbc(complete blood count) was drawn.The pre-procedure h/h was hgb 8.2/hct 27.6 and the h/h (hemoglobin and hematocrit) after the procedure was aborted was hgb 7.8/hct 25.4.The decision was made to repeat the procedure with a different device.The procedure was then completed without issue.It is estimated that the patient lost less than 200 cc of blood from the aborted procedure.The h/h the following morning hgb 8.3/hct 26.9.Fda safety report id # (b)(4).

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; lakewood CO 80215
• MDR Report Key: 15348199
• MDR Text Key: 299306184
• Report Number: MW5111843
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• 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: 08/30/2022

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Sex: Female
• Patient Weight: 50 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American