MAUDE Adverse Event Report: CAREFUSION MAXZERO EXTENSION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	MZXT9001
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the evaluation is pending.A follow up report will be submitted once the evaluation is completed.
Event or Problem Description
The customer reported that blood backed up into the line and saline leaked from the extension set when it was connected to the iv site.The set was removed and replaced with a new t-connector.There was no report of patient harm.
Event or Problem Description
The customer reported that blood backed up into the line and saline leaked from the extension set when it was connected to the iv site.The set was removed and replaced with a new t-connector.There was no report of patient harm.
Additional Manufacturer Narrative
The customer¿s report that blood backed up was confirmed visually; however, it was not replicated during testing.The customer¿s report of a fluid leak was not confirmed.Functional testing of priming and pressure testing did not replicate any signs of leaking on the received set.Infusion testing was successful with no leaking or alarms occurring.No instances of fluid backing up was replicated during testing.The root cause of the customer¿s report could not be identified.

• Brand Name: MAXZERO EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 7742821
• Report Number: 9616066-2018-01235
• Device Sequence Number: 1589096
• Product Code: FPA
• UDI-Device Identifier: 10885403240805
• UDI-Public: 10885403240805
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K140831
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 10/30/2020
• Device Model Number: MZXT9001
• Device Catalogue Number: MZXT9001
• Device Lot Number: 17107585
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/02/2018
• Supplement Report FDA Received Date: 10/29/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1