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

Model Number 2420-0007

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

Patient Problems Emotional Changes (1831); Distress (2329); No Code Available (3191)

Event Date 11/11/2018

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.Awake, alert, and oriented x4.Not at the facility for psych reasons.Blood loss was minor.

Event Description

The customer reported the tubing broke away completely from the leur lock.The patient experienced emotional distress/inconvenience.Fluid and some blood leaked.There's no report of lasting harm.

Event Description

It was reported that the tubing broke away completely from the luer lock.As a result, fluid and blood leaked, causing emotional distress and inconvenience to the patient.There was no report of lasting harm.

Manufacturer Narrative

The customer¿s complaint that the tubing separated from the male luer lock was confirmed.The only piece that was returned for evaluation was the male luer lock.The vinyl tubing engagement was completely separated from the male luer component.Visual inspection under magnification did not observed any tubing inside the inlet port of the male luer.No dimensional testing could be performed as the separation tubing was returned from the customer.The root cause of the customer¿s experience was not identified, the tubing engagement was not returned for evaluation.

• 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
• MDR Report Key: 8203598
• MDR Text Key: 131647038
• Report Number: 9616066-2018-02577
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other
• Type of Report: Initial,Followup
• Report Date: 12/03/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/11/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18083050
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2018
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other