MAUDE Adverse Event Report: CAREFUSION VITAL SIGNS; INFUSOR, PRESSURE, FOR I.V. BAGS

Device Problem Leak/Splash (1354)

Patient Problem No Information (3190)

Event Date 10/25/2017

Event Type  malfunction  

Event Description

Pressure bag was found to be leaking.

• Brand Name: VITAL SIGNS
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): CAREFUSION; 22745 savi ranch parkway; yorba linda CA 92887
• MDR Report Key: 7045583
• MDR Text Key: 92538194
• Report Number: 7045583
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2017

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
• Device Operator: Nurse
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/26/2017
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2017
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 11/20/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: NOT KNOWN.