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

Catalog Number ABC1499

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

Patient Problem Hypoglycemia (1912)

Event Date 10/22/2023

Event Type  Injury  

Event Description

It was reported that during a patient infusion of parenteral nutrition, the solution set leaked.It was further reported that the set was connected to a pump, and when the pump door was opened, it was identified that the set was damaged and loaded incorrectly.According to the reporter, the infused volume indicated by the pump did not match the remaining solution in the parenteral nutrition bag.The infusion was stopped, and the parenteral nutrition was withdrawn.As a result of the event, the patient developed hypoglycemia and received additional treatment of 50% dextrose.No additional information is available.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H10: the actual device was not available; however, ten (10) retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.The reported condition was not verified on the retained samples.The most probable cause of the condition is due to the misuse of the equipment by the end user.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SOLUTION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP 50 450; MX CP 50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18152822
• MDR Text Key: 328319050
• Report Number: 1416980-2023-05979
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412610245
• UDI-Public: (01)00085412610245
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 12/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ABC1499
• Device Lot Number: 50AIE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/12/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 09/02/2019
• 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: DEXTROSE; PARENTERAL NUTRITION; PUMP (ELVP001MEX)
• Patient Outcome(s): Required Intervention
• Patient Age: 44 YR
• Patient Sex: Male