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

Device Problem No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 04/14/2022

Event Type  Injury  

Event Description

It was reported that during patient infusion with an unknown access set, the patient experienced hypotension.The patient was receiving norepinephrine 4mg/250cc via central line.After a new bag of medication was started, the infusion was ¿continually titrated up with no response¿.The reporter stated that during the bag change, the clinician did not fully spike the bag; however, solution appeared to be flowing and drips in the drip chamber were noted.According to the reporter the drip chamber ¿had collapsed on itself¿.The spike was pushed further into the bag and the infusion was restarted.The patient was administered intravenous epinephrine and the blood pressure responded immediately.No additional information is available.

Manufacturer Narrative

The reported product is an unknown baxter access set.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: NI
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; ni; ni; ni
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 14548755
• MDR Text Key: 292982597
• Report Number: 1416980-2022-02746
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Risk Manager
• Type of Report: Initial,Followup
• Report Date: 06/23/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOREPINEPHRINE; SPECTRUM INFUSION PUMP
• Patient Outcome(s): Required Intervention