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

Model Number 12220

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/27/2023

Event Type  malfunction  

Event Description

Setting up the plasmapheresis machine, saline started leaking from the filter portion of the saline spike.Continuous drip does not stop dripping from the filter.The patient was not on the machine, and this was while we were preparing for the patient.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w collins ave; lakewood CO 80215
• MDR Report Key: 16712690
• MDR Text Key: 313043200
• Report Number: 16712690
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583122208
• UDI-Public: 05020583122208
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/03/2023

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 Model Number: 12220
• Device Lot Number: 2302036141
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/03/2023
• Date Report to Manufacturer: 04/11/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/11/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19345 DA
• Patient Sex: Male
• Patient Weight: 103 KG
• Patient Race: White