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

Model Number 20028E

Device Problems Fluid/Blood Leak (1250); Reflux within Device (1522)

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

Event Date 08/23/2016

Event Type  malfunction  

Manufacturer Narrative

No product will be returned per customer.The customer complaint could not be confirmed because the product was discarded and not returned for failure investigation.The root cause of this failure was not identified.

Event Description

The customer reported that when the remicade infusion was complete, the iv line backed up to the filter with blood.The filter and tubing were wet at the filter and a large area of the patient was wet.There is no report of patient harm.Received a copy of the customer's medwatch report from the fda which states, "remicade infusion was complete.The iv line backed up to filter with blood.The filter and tubing were wet at the filter site.A large area on the patient was wet.".

• 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: 6350235
• MDR Text Key: 68085110
• Report Number: 9616066-2017-00317
• 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: other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/01/2019
• Device Model Number: 20028E
• Device Catalogue Number: 20028E
• Device Lot Number: 16057257
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/24/2016
• 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: 77 YR
• Patient Weight: 75