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

Model Number 20029E

Device Problem Fluid/Blood Leak (1250)

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

Event Date 06/16/2017

Event Type  malfunction  

Manufacturer Narrative

Gtin/udi number for item (b)(4), lot 17037383 is 10885403234866.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

The customer reported a filter leak when infusing an unspecified medication.The events are occurring in the nicu.

Manufacturer Narrative

The customer¿s report of ¿filter leaked¿ was confirmed.No anomalies were observed during visual inspection.Functional testing confirmed leaking from the top air vent of the 0.2 micron filter.The root cause of the observed leak is due to a wetted out filter vent membrane.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• 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: 6747260
• MDR Text Key: 81183605
• Report Number: 9616066-2017-01037
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 07/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/23/2020
• Device Model Number: 20029E
• Device Catalogue Number: 20029E
• Device Lot Number: 17037383
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/08/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/24/2017
• 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
• Treatment: PRI TUBING, THERAPY DATE (B)(6) 2017