MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SECONDARY TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Lot Number SR 21K11042

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/24/2022

Event Type  malfunction  

Event Description

Patient transferred from sicu (surgical intensive care unit) with zosyn hung at 1447.It was hung as a secondary infusion with saline at 5cc as the primary.At 2100, i noticed it had not infused.I checked it and it had restarted the primary at 5cc; all clamps were open on primary and secondary.Pharmacy recommended rescanning it for 2100 and they would adjust the times.I changed it to another channel.

• Brand Name: SECONDARY TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; one baxter parkway; deerfield IL 60015
• MDR Report Key: 16371100
• MDR Text Key: 309485955
• Report Number: 16371100
• Device Sequence Number: 1
• Product Code: FPA
• 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: 02/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: SR 21K11042
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/08/2023
• Event Location: Hospital
• Date Report to Manufacturer: 02/14/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 27740 DA
• Patient Sex: Male
• Patient Weight: 61 KG