MAUDE Adverse Event Report: CAREFUSION ALARIS® PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR

Model Number PRI TUBING

Device Problem Fluid/Blood Leak (1250)

Patient Problem Death (1802)

Event Date 02/26/2018

Event Type  Death  

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 an infusion of 250ml of norepinephrine (8mg) was noted to have leaked. The patient had been weaned off the medication earlier in the day and the pump was turned off. They noticed drops of moisture on the iv pump that the tubing was programmed on and upon further investigation they found the leak to be coming from the y site of the tubing. There was no patient harm as a result of this event however the patient did pass away a few days later. The customer stated the tubing malfunction did not cause the patient¿s demise.

• Brand Name: ALARIS® PUMP MODULE 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: 7346803
• MDR Text Key: 102702991
• Report Number: 9616066-2018-00303
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health

Reporter Occupation

• Type of Report: Initial
• Report Date: 02/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 02/27/2018
• 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 Treatment Data

Date Received: 03/16/2018 Patient Sequence Number: 1