MAUDE Adverse Event Report: ICU MEDICAL; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	20130-01
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Event or Problem Description
Patient came from home as a direct admit after iv tubing broke at the spiro connection.Patient is on a continuous blinatumomab infusion at home.Infusion resumed and no harm was noted to the patient.There have been several reports of this type of event.

• Brand Name: ICU MEDICAL
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12576351
• Report Number: 12576351
• Device Sequence Number: 3255431
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/21/2021
• Report Date (Section F): 09/21/2021

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: 20130-01
• Device Catalogue Number: 20130-01
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/05/2021
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/05/2021
• 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 Weight: 20
• Date Report Sent to FDA: 09/21/2021