MAUDE Adverse Event Report: BAXTER HEALTHCARE - ATLACOMULCO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number ABC2707

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/30/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a solution set leaked from a hole in the tube.This occurred during infusion of parenteral nutrition.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was not returned; however, photographs were returned and evaluated.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Visual inspection of the images were not able to determine the components involved or any perforations or cuts.Retention samples were also visually inspected with no issues noted.The reported condition could not be verified.Should additional relevant information become available, a supplemental report will be submitted.It should be noted that according with the initial complaint description, the samples of the batch 88xle presented parenteral nutrition leakage; however, the use of the product code number: abc2707 is not recommended to infuse nutrition, due to the components of the solution dissolves the pvc of the set.

Manufacturer Narrative

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

• Brand Name: SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - ATLACOMULCO; atlacomulco
• Manufacturer (Section G): BAXTER HEALTHCARE - ATLACOMULCO; av. ing. salvador sanchez; colin no. 9; atlacomulco CP504 50; MX CP50450
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7160571
• MDR Text Key: 96364812
• Report Number: 1416980-2017-10163
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412475356
• UDI-Public: (01)00085412475356
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup,Followup
• Report Date: 07/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/17/2021
• Device Catalogue Number: ABC2707
• Device Lot Number: 88XLE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/03/2018
• Supplement Dates Manufacturer Received: 01/16/2018; 07/24/2018
• Supplement Dates FDA Received: 02/02/2018; 07/31/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 20 DA