MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SODIUM CHLORIDE INJECTION, USP, 1000 ML; CONTAINER, I.V.

Model Number 2B1324

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem Insufficient Information (4580)

Event Date 11/24/2021

Event Type  malfunction  

Event Description

Ns bag broke and leaked fluid over intra-aortic balloon pump (iabp) causing iabp to no longer work.

• Brand Name: SODIUM CHLORIDE INJECTION, USP, 1000 ML
• Type of Device: CONTAINER, I.V.
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 12915136
• MDR Text Key: 281587104
• Report Number: 12915136
• Device Sequence Number: 1
• Product Code: KPE
• 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: 11/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 2B1324
• Device Catalogue Number: NDC 0338-0049-04
• Device Lot Number: Y376822
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/29/2021
• Event Location: Hospital
• Date Report to Manufacturer: 12/02/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 23725 DA
• Patient Sex: Male