MAUDE Adverse Event Report: TERUMOBCT INC. SPECTRA OPTIA IDL SET; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Lot Number 1806283330

Device Problems Leak/Splash (1354); Improper or Incorrect Procedure or Method (2017)

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

Event Date 09/27/2018

Event Type  Injury  

Event Description

The pt had car t cells collected for kymriah manufacturing.At the end of the collection, the nurse sealed the bag appropriately and left it hanging on the iv pole on the spectra optia device.She turned away to complete other tasks and when she turned back to the product, noted that most of it had leaked from the collection bag via the sterile barrier filter line.She immediately tightened the blue cap on the end of the line and slid the slide clamp to obstruct the line.The line has a frangible that must be activated in order to use the line to inject anticoagulant and this had not been activated.She was under the impression that if the frangible was not activated, fluid could not be added or removed from the collection bag.Terumobct was contacted, (b)(4) was the representative who received the call.She informed me that fluid could possibly leak via the sterile barrier filter line even if the frangible was intact.She recommended making sure the slide clamp is used on the line during set up and to ensure the blue cap on the end of the line is secure.The staff has been educated regarding the process and our sop will be updated accordingly.Terumobct did not feel it was necessary to return the collection bag to them and it was disposed of per their recommendation.Therapy start date: (b)(6) 2018.Therapy end date: (b)(6) 2018.Reason for use: used for stem cell collections.

• Brand Name: SPECTRA OPTIA IDL SET
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMOBCT INC.
• MDR Report Key: 7934038
• MDR Text Key: 123072934
• Report Number: MW5080331
• Device Sequence Number: 0
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Device Operator: No Information
• Device Expiration Date: 06/01/2020
• Device Lot Number: 1806283330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/03/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization
• Patient Age: 61 YR
• Patient Weight: 59