MAUDE Adverse Event Report: TERUMO BCT, INC. COBE 2991; APPARATUS, AUTOTRANSFUSION

Catalog Number 90819

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Information (3190)

Event Date 07/12/2017

Event Type  malfunction  

Event Description

During red blood cell reduction of a bone marrow product on the cobe 2991 , a small leak occurred at the top of the wash set.Manufacturer response for cell processing set for cobe 2991, cell processing set (per site reporter):.

• Brand Name: COBE 2991
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 west collins ave; lakewood CO 80215
• MDR Report Key: 7117000
• MDR Text Key: 95005618
• Report Number: 7117000
• Device Sequence Number: 1
• Product Code: CAC
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2017
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Catalogue Number: 90819
• Device Lot Number: 04Z15002
• Other Device ID Number: BCP 2991
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/05/2017
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 12/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other