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

Model Number 20029E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

Patient Problem Therapeutic Response, Decreased (2271)

Event Type  Injury  

Event Description

The customer reported that a patient who was in an induced coma experienced decreased sedation related to the fentanyl infusion leaking from the connection between the primary set and extension set.A crack was noted in the female luer of the extension set.

Manufacturer Narrative

Although requested, the affected product has not been received.A follow up report will be submitted with investigation results should the devices be received for evaluation.

Manufacturer Narrative

The customer¿s report that the set leaked from a cracked female luer was not confirmed.The extension set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were noted.Functional and pressure testing were performed and no leaking was observed.The set's male luer and female luer were dimensionally tested and the set was found to be within specification.The root cause of the customer¿s report of the set leaking was not identified; the report that the leak came from a crack on the female luer was not confirmed.

Manufacturer Narrative

• Brand Name: ALARIS EXTENSION 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 4784897
• MDR Text Key: 18092563
• Report Number: 9616066-2015-00633
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/18/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/22/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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 Outcome(s): Other