MAUDE Adverse Event Report: HOSPIRA, INC./ICU MEDICAL LIFESHIELD PRIMARY PLUM Y-TYPE BLOOD SET 200 MICRON FILTER; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	1422028
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/19/2022
Type of Reportable Event	Malfunction
Event or Problem Description
Icu medical primary plum y-type blood set iv tubing received multiple cassette test failure notifications when initiating set up on iv pump.Multiple attempts made on different pumps with same failure message received.Total of four tubing sets tried with same failure message.

• Brand Name: LIFESHIELD PRIMARY PLUM Y-TYPE BLOOD SET 200 MICRON FILTER
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): HOSPIRA, INC./ICU MEDICAL; 275 n field drive; lake forest IL 60045
• MDR Report Key: 15128606
• Report Number: 15128606
• Device Sequence Number: 17517759
• Product Code: FPA
• UDI-Device Identifier: 10887787002475
• UDI-Public: 10887787002475
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 07/21/2022
• Report Date (Section F): 07/21/2022

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: 1422028
• Device Catalogue Number: 1422028
• Device Lot Number: 5893265
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 07/29/2022
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/29/2022
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Male
• Date Report Sent to FDA: 07/21/2022