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

Catalog Number 2H5660

Device Problem Backflow (1064)

Patient Problem Low Blood Pressure/ Hypotension (1914)

Event Date 12/12/2022

Event Type  Injury  

Manufacturer Narrative

Device manufacturer address 1: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported a patient was receiving an infusion of levophed using a micron extension set.While turning the patient, backed-up blood was observed in the port of the tunneled central line (placed in the intra-jugular).It was further reported blood also backed up "in the filter tubing" with subsequent interruption of infusion therapy and a drop in the patient's systolic blood pressure (bp) "to 50s".The filter was removed, and the medication was "reconnected to the patient with improvement of bp".No additional information is available.

Manufacturer Narrative

B5: upon follow up it was reported the patient was recovered from the drop in systolic blood pressure.The programmed flowrate of the levophed was71.4 cc/hr.And the propofol was 5.7 cc/hr.There was no alarm generated for the levophed; however, an alarm was generated for the propofol.The propofol iv line was flushed, and the extension set was changed.H10: the device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing, clear passage and under water pressure testing were performed with no issues noted.The reported condition was not verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 16122018
• MDR Text Key: 306913186
• Report Number: 1416980-2023-00009
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153158
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 2H5660
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/13/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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: SPECTRUM IQ PUMP
• Patient Outcome(s): Required Intervention