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

Model Number 20028E

Device Problems Break (1069); Fluid/Blood Leak (1250)

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

Event Date 03/08/2017

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

Received a copy of the customer's medsun report from fda, which states ¿ found total parenteral nutrition (tpn) filter with a crack and leaking.".

Manufacturer Narrative

The customer¿s report of a cracked filter was not confirmed.The extension set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No crack was observed on the set¿s 0.2 micron filter.No other anomalies were observed.Functional testing resulted in the set flowing freely and ran with no issues observed.Pressure testing confirmed leaking from the extension set¿s filter vent closest to the intake port.The root cause of the filter vent leak was identified as the fluid resistance of the filter becoming roughly equivalent to the fluid resistance of the air vent, increasing backpressure at which time the fluid seeks the path of least resistance through the filter vent.The source of the leak was determined to be from the extension set¿s 0.2 micron filter vent closest to the intake port.

• 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: 6788417
• MDR Text Key: 82589782
• Report Number: 9616066-2017-01165
• 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: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/03/2017
• 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 Age: 11 DA