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

Catalog Number ASKU

Device Problems Improper or Incorrect Procedure or Method (2017); No Flow (2991)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Type  Injury  

Manufacturer Narrative

The reported product is an unknown baxter access set.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.

Event Description

It was reported that a partial clamp closure of an unknown access set was observed during a patient infusion of neo-synephrine.The reporter stated the patient¿s blood pressure (bp) was dropping and a bolus was administered; however, "when the infusion returned to the maintenance rate, the bp dropped".The patient was transferred to the intensive care unit (icu) and the receiving nurse noticed that the intravenous (iv) tubing was partially occluded with the blue slide clamp.Treatment for the event was not reported.At the time of this report, the patient outcome was not reported.No additional information is available.

• 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: 15051608
• MDR Text Key: 296130546
• Report Number: 1416980-2022-03695
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/19/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/19/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/23/2022
• 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: NEO-SYNEPHRINE; SPECTRUM IQ INFUSION PUMP
• Patient Outcome(s): Other