MAUDE Adverse Event Report: TERUMO BCT, INC. SPECTRA OPTIA; SEPERATOR, AUTOMATED, BLOOD CELL AND PLASMA THERAPEUTIC

Lot Number IP04152

Device Problem Break (1069)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/23/2019

Event Type  malfunction  

Event Description

Patient had significant blood loss due to equipment malfunction during plasmapheresis possibly due to broken line in inside machine centrifuge.The patient¿s fibrinogen level dropped from 170/dl (low) to 72mg/dl (critical level) requiring transfusion with ffp and medication to prevent historical life-threatening allergic response to plasma.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPERATOR, AUTOMATED, BLOOD CELL AND PLASMA THERAPEUTIC
• Manufacturer (Section D): TERUMO BCT, INC.
• MDR Report Key: 8293710
• MDR Text Key: 135148738
• Report Number: MW5083581
• 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: Nurse
• Type of Report: Initial
• Report Date: 01/25/2019

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 Lot Number: IP04152
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• 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 Outcome(s): Other
• Patient Age: 68 YR
• Patient Weight: 65