MAUDE Adverse Event Report: HOSPIRA, INC. PLUM; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1424228
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While setting up infusion for patient and the cassette portion of the iv broke into pieces.The staff did not give any more information than what was provided.It apparently happened on more than one occasion.They changed sets and continued the care they were providing.

• Brand Name: PLUM
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 7756336
• Report Number: 7756336
• Device Sequence Number: 13773159
• Product Code: FPA
• UDI-Device Identifier: 10887787006237
• UDI-Public: (01)10887787006237
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 07/17/2018
• Report Date (Section F): 07/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 1424228
• Device Catalogue Number: 1424228
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 08/07/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 07/17/2018