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

Model Number	MZ9271
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Inadequate Pain Relief (2388)
Date of Event	05/14/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The customer¿s report that the bifuse and filter were leaking was not confirmed.Visual inspection showed no anomalies.Priming, functional testing, and pressure testing resulted in no leaking.The root cause of the customer¿s report could not be determined.
Event or Problem Description
The customer reported that during a fentanyl infusion, the patient was moving his arms and legs constantly, had a hr in the 180s and his right leg had occasional tremors.The patient received five unspecified prn medications through the night.In the morning, the infusion was assessed and fluid was found leaking from the bifuse and filter of the fentanyl infusion.The tubing was replaced.There was no report of long term patient harm.

• 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: 7768329
• Report Number: 9616066-2018-01232
• Device Sequence Number: 2218423
• Product Code: FPA
• UDI-Device Identifier: 10885403240744
• UDI-Public: 10885403240744
• 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
• 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?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MZ9271
• Device Catalogue Number: MZ9271
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRI TUBING,8015,8100,(2)MZ9265,MZ9271, TD (B)(6) 2018
• Outcome Attributed to Adverse Event: Other
• Patient Age: 14 DA