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

Model Number	ME1224
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Information (3190)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.Although patient age and dob has not been provided, it is presumed that the patient was an infant as the pediatric and picu manager reported the event.
Event or Problem Description
It was reported that the nurses stated that there are frequent events in which the trifuse tubing set leaked during patient use.
Additional Manufacturer Narrative
Correction: although this file was opened to capture the unspecified number of reported events that occurred during use on a unspecified number of patients, it is presumed that the patient's were pediatric patients as the pediatric/picu manager reported the events.
Event or Problem Description
It was reported that the nurses have stated that there have been frequent events in which the trifuse tubing sets were found to leak during patient use, both in the past and currently, however, the staff have not appropriately reported it or addressed the issue.

• Brand Name: MAXGUARD EXTENSION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8898817
• Report Number: 9616066-2019-02333
• Device Sequence Number: 13859969
• Product Code: FPA
• UDI-Device Identifier: 10885403236112
• UDI-Public: 10885403236112
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/10/2019

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
• Operator of Device: Health Professional
• Device Model Number: ME1224
• Device Catalogue Number: ME1224
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/15/2019
• Supplement Report FDA Received Date: 09/05/2019
• 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: 8100,8015, PRI TUBING, THERAPY DATE UNKNOWN; 8100,8015, PRI TUBING, THERAPY DATE UNKNOWN