MAUDE Adverse Event Report: BIOCOMPATIBLES U.K. LIMITED THERASPHERE; YTTRIUM-90 MICROSPHERES

Lot Number 4990105

Device Problems Improper or Incorrect Procedure or Method (2017); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Information (3190)

Event Date 05/28/2014

Event Type  Injury  

Event Description

(b)(4) customer service received a call from a medical physicist at (b)(6).They wanted to re-order a therasphere dose for a pt.When asked the reason they needed the dose replaced they responded that the reason the 4 gbg dose was no longer available was it had been given to the wrong pt.It had been waiting in storage to be used later that day on the proper pt when it was given to a different pt who was in there for an "angio".The medical physicist ordering the dose said that they didn't want to complain officially because they didn't want their name on any of the paperwork as they had nothing to do with the situation.

Manufacturer Narrative

This was a report of user error.Multiple f/u attempts (vms on (b)(4).Email's to the (b)(4) and medical physicist (b)(4)) to the hospital resulted in no add'l info on the pt outcome being shared by the hosp.The only info we were able to get from the hosp was in the form of an email which stated "let's just say that it had nothing to do with the scheduled theraspheres pt, and everything to do with a failure to follow policies in nuclear medicine and special procedures.It was very unfortunate for our pt, whose treatment was set back almost 2 more weeks, but she is now scheduled to receive her second lobe treatment on (b)(6)." the medical assessment of this event was that user error is reportable and in the absence of info on the pt outcome this event must be reported.The administration of therasphere radioactive microspheres to a pt other than the intended pt could possibly lead to a serious injury.

• Brand Name: THERASPHERE
• Type of Device: YTTRIUM-90 MICROSPHERES
• Manufacturer (Section D): BIOCOMPATIBLES U.K. LIMITED; farnham ; UK
• Manufacturer Contact: chapman house, farnham bus.; park, weydon ln; farnham, surrey england GU9 8-QL ; 6138011847
• MDR Report Key: 3909524
• MDR Text Key: 4584852
• Report Number: 3002124545-2014-00015
• Device Sequence Number: 1
• Product Code: NAW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: H980006
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 06/06/2014
• Device Lot Number: 4990105
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other