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

Model Number 2420-0007

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

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 101ml of insulin (100units) in ns was noted to be leaking from a small hole in the tubing while connected to a patient.There was no patient harm.

Event Description

The customer reported that 101ml of insulin (100units) in ns was noted to be leaking from a small hole in the tubing while connected to a patient.There was no patient harm.

Manufacturer Narrative

The customer¿s report of leaking from a small hole in the tubing was confirmed.Visual inspection showed that the silicone segment had a tear near the upper fitment measuring 0.0917 inches long.Examination under magnification showed no crush marks to the upper fitment.Functional testing was performed and leaking from the silicone tubing near the upper fitment was observed.The root cause of the leak was a tear in the silicone segment.The cause of the tear was not determined.

• 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: 7639545
• MDR Text Key: 112434637
• Report Number: 9616066-2018-00916
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 05/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/08/2021
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 18025598
• Other Device ID Number: 7613203021012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Date Manufacturer Received: 05/30/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1