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

Model Number 20027E

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

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

The customer reported a leak occurred at the filter during an infusion.No patient harm was reported.

Manufacturer Narrative

The customer¿s report of a leak occurred at the filter during an infusion was confirmed.Visual inspection of the set noted that the outlet port tubing was completely broken and detached from the 0.2 micron filter.The outlet port pivot of the filter was observed to be broken off and still inside the tubing sleeve.Stress marks were observed on the area where the outlet port pivot is attached to the filter body.There were no other anomalies observed.Functional testing was deemed unnecessary due to separation.Dimensional analysis was not able to be performed as part of the filter¿s outlet port pivot that connects to the tubing, was broken off and was inside the tubing sleeve.The cause of the leak at the set¿s 0.2 micron filter was due to the filter¿s outlet port pivot being completely broken and detached from the filter.The root cause of the broken 0.2 micron filter outlet port pivot was identified as supplier assembly, handling, and shipping processes.

Event Description

The customer reported a leak occurred at the filter during an infusion.No patient harm was reported.

• Brand Name: ALARIS EXTENSION SET
• Type of Device: SET, EXTENSION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8289132
• MDR Text Key: 134493068
• Report Number: 9616066-2019-00162
• Device Sequence Number: 1
• Product Code: FPB
• UDI-Device Identifier: 10885403234859
• UDI-Public: 10885403234859
• Combination Product (y/n): N
• PMA/PMN Number: K801614
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Type of Report: Initial,Followup
• Report Date: 01/03/2019

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 Expiration Date: 09/18/2021
• Device Model Number: 20027E
• Device Catalogue Number: 20027E
• Device Lot Number: 18096146
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/30/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: PRI TUBING, THERAPY DATE: UNK; PRI TUBING, THERAPY DATE: UNK