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

Model Number 12220

Device Problem Crack (1135)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 07/20/2022

Event Type  malfunction  

Event Description

Forty-five (45) minutes into patients apheresis treatment, something in the line cracked.This caused blood to spray all over the centrifuge requiring biomed to help clean out the machine.Because of this rn was unable to rinse back the patient's blood during treatment so patient loss some blood as a result.Fda safety report id# (b)(4).

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC; lakewood CO 80215
• MDR Report Key: 15174146
• MDR Text Key: 297500236
• Report Number: MW5111277
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583122209
• UDI-Public: 35020583122209
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 08/02/2022

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
• Device Expiration Date: 01/01/2024
• Device Model Number: 12220
• Device Lot Number: 2201251261
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 71 KG
• Patient Ethnicity: Hispanic
• Patient Race: White