MAUDE Adverse Event Report: CAREFUSION MAXGUARD SECONDARY ADMINISTRATION SET; SET,ADMIN, INTRAVASCULAR.

Model Number	MS3500
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: senior specialist.No product will be returned per customer.No investigation was performed.Although requested, patient demographics not provided.
Event or Problem Description
It was reported that the secondary chemotherapy infusion would not flow through the primary line unless the primary clamp was closed then reopened to allow the chemo to infuse.They indicated there was a minor affect on the patient since there was an inaccurate administration of chemotherapy.They stated there was no harm.
Event or Problem Description
It was reported that the secondary chemotherapy infusion would not flow through the primary line unless the primary clamp was closed then reopened to allow the chemo to infuse.They indicated there was a minor affect on the patient since there was an inaccurate administration of chemotherapy.They stated there was no harm.

• Brand Name: MAXGUARD SECONDARY ADMINISTRATION SET
• Common Device Name: SET,ADMIN, INTRAVASCULAR.
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8529548
• Report Number: 9616066-2019-01101
• Device Sequence Number: 14082385
• Product Code: FPA
• UDI-Device Identifier: 10885403222603
• UDI-Public: 10885403222603
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/04/2019

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: MS3500
• Device Catalogue Number: MS3500
• 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: 04/18/2019
• Supplement Report FDA Received Date: 05/02/2019
• 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: PRI TUBING, THERAPY DATE (B)(6) 2019