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

Model Number PRI TUBING

Device Problems Insufficient Information (3190); Appropriate Term/Code Not Available (3191)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

No device will be returned per customer.The customer complaint could not be confirmed because the device was not sequestered for failure investigation.The root cause of this failure was not identified.

Event Description

During a site visit, it was reported to a bd representative that air-in-line occurs with bubbly medication in the pediatrics intensive care unit.No further information is available.And the bd representative stated their was no patient involvement to their knowledge.

Manufacturer Narrative

Suspect changed to pri tubing.

Event Description

During a site visit, it was reported to a bd representative that air-in-line occurs with bubbly medication in the pediatrics intensive care unit.There is no patient involvement to the bd representative's knowledge.No further information is available.

Manufacturer Narrative

After further review, this file was made non-reportable on (b)(6)2020.

Event Description

During a site visit, it was reported to a bd representative that air-in-line occurs with bubbly medication in the pediatrics intensive care unit.Their is no patient involvement to the bd representative's knowledge.No further information is available.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMIN, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 9582536
• MDR Text Key: 175020339
• Report Number: 2016493-2020-00091
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K133532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PRI TUBING
• Device Catalogue Number: PRI TUBING
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/13/2020
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 02/13/2020; 03/02/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING, 8015, THERAPY DATE UNKNOWN