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

Model Number 2000E

Device Problem Restricted Flow rate (1248)

Patient Problem Death (1802)

Event Date 07/16/2018

Event Type  Death  

Manufacturer Narrative

Concomitant medical products: d-60hl rapid infuser tubing, continu-flow solution set, 10 drops/ml product number: 2c8541, therapy date: (b)(6) 2018.No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that the patient needed the use of pressure bags and a level 1 rapid infuser for multiple infusions and transfusions through multiple central lines.The users noticed impeded flow during the infusions.The rapid infuser and the tubing that appeared to be malfunctioning were replaced and the customer ensured that each iv port was flowing adequately, however the decreased flow rate continued.After placement of another large bore central line, the flow issue persisted.The physician felt that the needle free valve did not tolerate the high pressure required and may not have been compatible with the infuser tubing.A non-bd needlefree valve was used instead with no issues.The patient was further resuscitated, was later placed on comfort care, and passed away.An autopsy was declined by the patient's family and attending physicians.The customer does not believe the product issue caused the patient's death.

• Brand Name: 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 7769138
• MDR Text Key: 116631311
• Report Number: 9616066-2018-01256
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203011938
• UDI-Public: 7613203011938
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K061285
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 2000E
• Device Catalogue Number: 2000E
• Was Device Available for Evaluation?: No
• 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
• Treatment: (2) LEVEL 1 RAPID INFUSER, THERAPY DATE: (B)(6) 2018
• Patient Outcome(s): Death