MAUDE Adverse Event Report: CAREFUSION ALARIS® GRAVITY ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 10010903

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

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

Event Type  malfunction  

Manufacturer Narrative

The customer¿s complaint of a pin hole leak could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

Received a copy of the customer's medwatch report from the fda which states, "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." an incomplete date of event of (b)(6) 2018 was provided.No patient harm.

• Brand Name: ALARIS® GRAVITY ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: stephen bilello ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7656041
• MDR Text Key: 113004073
• Report Number: 9616066-2018-00927
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K882302
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10010903
• Device Catalogue Number: 10010903
• Other Device ID Number: 7613203020879
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 55 YR