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

Model Number 2426-0500

Device Problems Fluid/Blood Leak (1250); Material Separation (1562)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/23/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The customer reported that the tubing set was primed with perjeta in the med room and no leaking was noted at that time.When the clinician placed the tubing into the pump and closed the door the tubing separated and leaked.The area was cleaned in compliance with the facility's chemotherapy spill/clean up policy.There was no report of patient involvement.

• 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: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 8197128
• MDR Text Key: 131591640
• Report Number: 9616066-2018-02601
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203020992
• UDI-Public: 7613203020992
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 11/26/2018

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 Expiration Date: 07/10/2021
• Device Model Number: 2426-0500
• Device Catalogue Number: 2426-0500
• Device Lot Number: 18073047
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/26/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/10/2018
• 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