MAUDE Adverse Event Report: CAREFUSION 303, INC GRAVITY NON-VENTED BLOOD SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 10010903

Device Problems Hole In Material (1293); Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 05/11/2018

Event Type  malfunction  

Event Description

A pinhole leak was noted on a "pressure pump" of blood tubing (smartsite gravity blood set with pressure pump ref 10010903, lot +h370100109031) after blood began infusing.We stopped infusion, and notified the surgeon who ordered a change to new tubing and to continue infusion.I believe it did happen on two different occasions.

• Brand Name: GRAVITY NON-VENTED BLOOD SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION 303, INC; 10020 pacific mesa blvd.; san diego CA 92121
• MDR Report Key: 7577950
• MDR Text Key: 110357103
• Report Number: 7577950
• Device Sequence Number: 1
• Product Code: FPA
• 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: 05/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2018
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 10010903
• Device Lot Number: +H370100109031
• Other Device ID Number: SMARTSITE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/14/2018
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2018
• 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
• Treatment: NO; NOT APPLICABLE.
• Patient Age: 55 YR