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

Catalog Number EXACTAM

Device Problem Crack (1135)

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

Event Date 07/20/2021

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.External visual inspection was performed and a crack was observed in the main housing, however the device still operated as intended.Unknown fluids were found on the device.Functional testing was performed with no issues noted.The reported issue of main module cracked front panel below rotor platform was verified.The cause of the condition could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the green door of an exactamix automated compounding device was damaged.It was further reported that there was crack on the door front panel of the rotor platform.There was no patient involvement.No additional information is available.

• 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 ; 2242702068
• MDR Report Key: 12309118
• MDR Text Key: 266082370
• Report Number: 1416980-2021-04949
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 05413765570131
• UDI-Public: (01)05413765570131
• Combination Product (y/n): Y
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/11/2021

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: Other
• Device Catalogue Number: EXACTAM
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2021
• Initial Date Manufacturer Received: 07/20/2021
• Initial Date FDA Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1