MAUDE Adverse Event Report: CAREFUSION ALARIS EXTENSION SET; SET, EXTENSION, INTRVASCULAR

Model Number 20027E

Device Problems Crack (1135); Fluid/Blood Leak (1250)

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

Event Date 09/08/2016

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 a 0.2 micron filter extension set was cracked and leaked during a tpn infusion.The leak was found soon after starting the infusion.There is no report of patient harm.Received a copy of the customer's medwatch report from the fda which states, "a 0.2 micron filter extension set was damaged or defective.The filter cracked and leaked; the nurse noticed the leak soon after starting the infusion before any delay in therapy or harm to patient.".

Manufacturer Narrative

The customer¿s report that an extension set cracked and leaked was confirmed.During visual inspection it was observed that the female luer had a vertical hair line crack that measured 0.473 inches long.Inspection under magnification showed no stress/ tool marks.Functional and pressure testing confirmed leaking from the crack.The probable cause of the crack and leak at the set¿s female luer is a combination of material degradation during the supplier process and manufacturing factors.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRVASCULAR
• 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: 6130338
• MDR Text Key: 60990666
• Report Number: 9616066-2016-01646
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 11/07/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/30/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/12/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Weight: 2