MAUDE Adverse Event Report: TERUMO BCT, INC SPECTRA OPTIA; SEPARATOR, AUTOMATED

Lot Number 11W3106

Device Problem Crack (1135)

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

Event Date 12/11/2014

Event Type  malfunction  

Event Description

Patient was receiving treatment and during the procedure one of the plastic tubes developed a small crack.The md was notified and rinse back done.During rinseback another machine was primed with new tubing.Once the rinse back was completed the patient was disconnected from one machine and immediately connected to another and the treatment resumed until completion.This was not a malfunction of the machine but a crack in the disposable tubing.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED
• Manufacturer (Section D): TERUMO BCT, INC; 10811 west collins ave.; lakewood CO 80215
• MDR Report Key: 4397155
• MDR Text Key: 5121197
• Report Number: 4397155
• Device Sequence Number: 1
• Product Code: LKN
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/30/2014

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: Other
• Device Lot Number: 11W3106
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/30/2014
• Event Location: Hospital
• Date Report to Manufacturer: 01/08/2015
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/30/2014
• Patient Sequence Number: 1
• Patient Age: 57 YR
• Patient Weight: 159