MAUDE Adverse Event Report: TERUMO BCT OPTIA

Lot Number 1790083230

Device Problems Clumping in Device or Device Ingredient (1095); Failure to Deliver (2338); Device Displays Incorrect Message (2591)

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

Event Date 04/04/2018

Event Type  Injury  

Event Description

Optia machine alarmed return pressure at approx.141 mins into the cmnc procedure.At this time the rn assessed the patient's cvl and noted return line to flush sluggishly and not give a blood return.Md notified as rn continued to assess both the pt's lines as well as product/machine.At this time rn noted small amount of clumping in the hpc collection bag and then some clumping/sticking in the return line of optia.At this time the md was at bedside and ordered for procedure to be aborted.Patient was then cared for while a second rn labeled, packaged, and prepared the product for transport to the processing facility.

• Brand Name: OPTIA
• Type of Device: OPTIA
• Manufacturer (Section D): TERUMO BCT
• MDR Report Key: 7171479
• MDR Text Key: 96735661
• Report Number: MW5074440
• 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: 01/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2019
• Device Lot Number: 1790083230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 6 YR
• Patient Weight: 15