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

Catalog Number	EXACTAM
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the main module door of an exactamix automated compounding device (acd) was damaged.The damaged door was further described as, ¿in fault state / door that houses rotor and tubing won't close.Is unhinged¿.This issue was observed during an unspecified process step prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: the device was received for evaluation.A visual inspection was performed which observed the device was in used condition.The unit was in a constant pump fault state and the pump door cover was missing a shoulder screw.An electrical safety test was performed in which the device passed testing.Functional system level tests were performed which found the pump was faulted.The reported conditions were verified.The cause of the reported condition of the pump fault was due to a faulty pump motor driver pca with an overheated (blown) chip and the cause of the unhinged pump door cover due to the missing screw; it is unknown how screw became missing.The pump motor and door will be replaced to resolve the issue.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
• Common Device Name: 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: 17436554
• Report Number: 1416980-2023-03862
• Device Sequence Number: 8884990
• Product Code: NEP
• UDI-Device Identifier: 00085412586557
• UDI-Public: (01)00085412586557
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/05/2023

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
• Operator of Device: Other
• Device Catalogue Number: EXACTAM
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2023
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/24/2023
• Initial Report FDA Received Date: 08/01/2023
• Supplement Report FDA Received Date: 09/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown