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

Catalog Number ABC2707

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Patient Involvement (2645)

Event Date 08/02/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified infusion pump displayed an alarm while being used with a solution set.The set was switched to another pump, but that pump also started alarming.The exact alarm was not reported.This issue occurred during setup.The set was connected to nutrition at the time of the event.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The actual sample and ten (10) retained samples were received for evaluation.Visual inspection on the returned samples did not identify any abnormalities that could have contributed to the reported condition.The actual sample was not contained in the primary package.The actual and retained samples showed that the tubing was in good condition.Functional testing was not performed since it was no information about the alarm.Alarms described in the pump guide are related to the handling of the set.The reported problem was not verified.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 - 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: 7838691
• MDR Text Key: 118946481
• Report Number: 1416980-2018-05559
• 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
• Report Date: 10/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/25/2022
• Device Catalogue Number: ABC2707
• Device Lot Number: 85YKE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/04/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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