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 Date 12/06/2017

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 a tear in the silicone pumping segment and leaked.There was no patient harm.Received a copy of the customer's medwatch report from the fda which states, "the nurse entered the room to find a puddle qf fluid on the floor around the iv pole and noticed fluid dripping from the iv pump module.She opened the module and noted a hole in the tubing where fluid was running.".

Manufacturer Narrative

The customer¿s report that the silicone segment tore and leaked was confirmed.Visual inspection showed that the silicone segment had a tear near the upper fitment measuring 0.1610 inches long.Inspection under magnification showed no crush mark to the upper fitment.Functional and pressure testing resulted in a leak from the silicone tubing near the upper fitment.The cause of the leak was a tear in the silicone segment.

• 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: 7176996
• MDR Text Key: 96814253
• Report Number: 9616066-2018-00042
• 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: health professional,other,use
• Type of Report: Initial,Followup
• Report Date: 12/20/2017

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: 2420-0007
• Device Catalogue Number: 2420-0007
• Other Device ID Number: 7613203021012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/24/2018
• Initial Date Manufacturer Received: 12/20/2017
• Initial Date FDA Received: 01/09/2018
• Supplement Dates Manufacturer Received: 03/05/2018
• Supplement Dates FDA Received: 03/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8015,8100, THERAPY DATE (B)(6) 2017