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

Model Number 20029E

Device Problem Crack (1135)

Patient Problems High Pulmonary Arterial Wedge Pressure (2480); No Known Impact Or Consequence To Patient (2692)

Event Date 09/24/2016

Event Type  Injury  

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.

Event Description

The customer reported that the tubing cracked where it had been clamped.Patient had pulmonary hypertensive crisis.There was no report of patient harm.

Manufacturer Narrative

Unable to determine the cause of the customer's reported complaint because the set has been discarded by the customer and will not be returned.The root cause of this failure could not be identified.

Event Description

It is unknown if the set leaked; however, the customer indicated that the delivery of the sedation drips was affected, which led to the pulmonary hypertensive crisis.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, 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: 6200873
• MDR Text Key: 63198639
• Report Number: 9616066-2016-01905
• Device Sequence Number: 1
• Product Code: FPB
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/14/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/11/2017
• 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 Outcome(s): Required Intervention
• Patient Age: 9 MO
• Patient Weight: 9