MAUDE Adverse Event Report: TERUMO SPECTRA OPTIA; TUBING

Lot Number 1711163230

Device Problem Material Rupture (1546)

Patient Problem Blood Loss (2597)

Event Date 12/11/2017

Event Type  malfunction  

Event Description

Spectra optia tubing set ruptured as therapeutic plasma exchange treatment started.Patient had 165 ml blood loss (amount in set).Treatment performed on cobe spectra machine.

• Brand Name: SPECTRA OPTIA
• Type of Device: TUBING
• Manufacturer (Section D): TERUMO
• MDR Report Key: 7116555
• MDR Text Key: 94939456
• Report Number: MW5073954
• Device Sequence Number: 1
• Product Code: LKN
• 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
• Type of Report: Initial
• Report Date: 12/12/2017

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 Expiration Date: 11/01/2019
• Device Lot Number: 1711163230
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/13/2017
• 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: 52 YR