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 02/09/2018

Event Type  malfunction  

Manufacturer Narrative

The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.

Event Description

Received a copy of the customer's medsun from fda, which states ¿fluid noted to be dripping from the pump.When the channel was opened it was noted that the tubing was leaking.Upon inspection, tubing noted to have a small hole at the connection between the top blue piece and the soft part of the tubing." the medication that was administered was either d51/2 with 20kcl or zosyn 4,500mg.There was no patient harm.

Manufacturer Narrative

The customer¿s report of the set leaking at the pump segment was confirmed.Visual inspection of the set showed that the silicone segment had a tear near the upper fitment measuring 0.0378 inches long.Examination under magnification showed no crush marks to the upper fitment.Functional and pressure testing confirmed leaking from the silicone tubing near the upper fitment.The cause of the leak was a tear in the silicone segment.The cause of the tear is unknown.

• 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: 7360004
• MDR Text Key: 103172938
• Report Number: 9616066-2018-00329
• 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,user faci
• Type of Report: Initial,Followup
• Report Date: 03/02/2018

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 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: 03/19/2018
• Initial Date Manufacturer Received: 03/02/2018
• Initial Date FDA Received: 03/21/2018
• Supplement Dates Manufacturer Received: 05/25/2018
• Supplement Dates FDA Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: 8100,8015,1000ML BAXTER IV BAG, TD (B)(6) 2018