MAUDE Adverse Event Report: SVS LLC PREMIERPRO; INFUSOR, PRESSURE, FOR I.V. BAGS

Model Number 8818

Device Problems Deflation Problem (1149); Leak/Splash (1354)

Patient Problem Insufficient Information (4580)

Event Date 02/14/2023

Event Type  malfunction  

Event Description

The bag deflated about 2 hours after the mitral clip case started.User could not pump air into it and could hear it just leaking into the room w/each pump.There was enough pressure on the bag that the user couldn't remove the saline bag from the pressure bag.Grabbed a new bag to pressurize.Manufacturer response for 1000cc pressure bag, (brand not provided) (per site reporter).Took description of problem, issue rga#: 23-148.

• Brand Name: PREMIERPRO
• Type of Device: INFUSOR, PRESSURE, FOR I.V. BAGS
• Manufacturer (Section D): SVS LLC; 13034 ballantyne corporate place; charlotte NC 28277
• MDR Report Key: 16609475
• MDR Text Key: 311959315
• Report Number: 16609475
• Device Sequence Number: 1
• Product Code: KZD
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 8818
• Device Catalogue Number: 8818
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/02/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/22/2023
• Event Location: Hospital
• Date Report to Manufacturer: 03/24/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1