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

Catalog Number 10220

Device Problem Leak/Splash (1354)

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

Event Date 07/05/2019

Event Type  malfunction  

Event Description

Approx.2 min.Into rinseback of therapeutic plasma exchange, nurse noted there was leakage under the kit's cassette near where the return tubing exits out of the kit's cassette.Nurse immediately clamped the return line, the draw line was already clamped, stopped the rinseback, and disconnected the patient from the machine.The pheresis catheter was soon removed by doctor.Terumo was called and will send service rep.To check the machine.The kits with the same lot number were sequestered and the affected kit was placed in a biohazard bag and was mailed to the company.

• Brand Name: SPECTRA OPTIA APHERESIS SYSTEM
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave; lakewood CO 80215
• MDR Report Key: 8968891
• MDR Text Key: 156733760
• Report Number: 8968891
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

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 Catalogue Number: 10220
• Device Lot Number: 1904233130
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/11/2019
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/27/2019
• Device Age: 9 YR
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 09/06/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 26645 DA