MAUDE Adverse Event Report: CAREFUSION SMARTSITE NEEDLE-FREE VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2000E7D

Device Problem Fluid/Blood Leak (1250)

Patient Problem Cardiopulmonary Arrest (1765)

Event Date 01/01/2018

Event Type  Injury  

Manufacturer Narrative

The model#/catalog# identified in section is a carefusion product which is same or similar to a device that is approved for sale domestically.The domestic similar list number is (b)(4).The 510k number provided in section is for the domestic similar product.The customer¿s complaint could not be confirmed because the product was not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that a smartsite needlefree valve was connected to the ecmo circuit via a three-way stopcock.The patient's condition suddenly deteriorated when an attempt was made to draw blood from the smartsite.On closer inspection it was identified that the smartsite was not functioning correctly and had allowed fluid and air into the circuit.The ecmo circuit was clamped and the patient was resuscitated.The air was removed from the circuit, the ecmo was re-connected again, and the patient stabilized.

Manufacturer Narrative

The customer¿s report that the smartsite was not functioning correctly was confirmed from a video provided by the customer which showed fluid leaking out of the end of the smartsite component.Further correspondence with the customer has indicated that the sample that was found to leak was oval in shape.The root cause of the deformation and leakage (oval female luer adapter) is exposure of the smartsite® to an external heat source.

• Brand Name: SMARTSITE NEEDLE-FREE VALVE
• 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: 7224884
• MDR Text Key: 98463206
• Report Number: 9616066-2018-00074
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2020
• Device Model Number: 2000E7D
• Device Catalogue Number: 2000E7D
• Device Lot Number: 1003952
• Other Device ID Number: 07613203013611
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/12/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 03/28/2017
• 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
• Treatment: ECMO CIRCUIT, THERAPY DATE (B)(6) 2018
• Patient Outcome(s): Required Intervention