MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX ROHS MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number EXACTAM

Device Problems Break (1069); Difficult to Open or Close (2921)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/09/2023

Event Type  malfunction  

Manufacturer Narrative

E1: initial reporter address: (b)(6) should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the exactamix main module door was damaged which led to the door not being able to be closed.This issue was further described as, ¿rotor door not closed error¿.This occurred during programming/setup prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: the device was received for evaluation.Visual inspection was performed, and the main module cover was observed to be corroded, contaminated, and cracked/broken.The green pump cover was damaged/broken.Hi-pot electrical safety test was performed, and the device passed testing.Sf1 functional system level system test was performed, and the device passed testing.Sf2 functional system level ctf testing was performed, and the device failed for ¿port 9 failed to open¿.The device was disassembled and cleaned, and the device was retested on ctf and no longer produced errors.The main module did not produce any rotor door not closed errors.The reported rotor door not closed errors was not verified.The cause of the damaged door was not determined.A service history review was performed which revealed that the device had no service history within the past 12 months.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXACTAMIX ROHS MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): PLEXUS CORPORATION; 2500 millbrook drive; buffalo grove IL 60089
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18274879
• MDR Text Key: 329839010
• Report Number: 1416980-2023-06350
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: EXACTAM
• Device Lot Number: PL0020420
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/16/2024
• 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: NA.