MAUDE Adverse Event Report: SORIN SMART PRIMO2X; SMART PERFUSION PACK

Catalog Number 088504801

Device Problems Fluid/Blood Leak (1250); Loose or Intermittent Connection (1371); Structural Problem (2506)

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

Event Date 12/05/2014

Event Type  malfunction  

Event Description

While on cardiopulmonary bypass, the arterial bypass bridge connector started dripping pretty profusely.Cobe tie appeared to be loose and connector appeared to not be glued together.Two ne cobe ties were applied which seemed to slow leak down.

• Brand Name: SMART PRIMO2X
• Type of Device: SMART PERFUSION PACK
• Manufacturer (Section D): SORIN
• MDR Report Key: 4342346
• MDR Text Key: 5217473
• Report Number: MW5039617
• Device Sequence Number: 1
• Product Code: DTZ
• 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: 12/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/10/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2016
• Device Catalogue Number: 088504801
• Device Lot Number: 1430300054
• Other Device ID Number: 088504901
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1