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

Catalog Number EXACTAM

Device Problem Device Emits Odor (1425)

Patient Problem No Patient Involvement (2645)

Event Date 12/23/2020

Event Type  malfunction  

Manufacturer Narrative

Initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the main module of an exactamix automated compounding device had a burning smell while powered on.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction made to h10: a device history review was not performed, (previously submitted, as a device history review revealed, no issues that could have caused or contributed to the reported issue).

Manufacturer Narrative

Additional information in h3 and h6.H10: the device was received for evaluation.A visual inspection was performed and discovered that the pump stepper motor driver pca has burnt components (u12).It's possibly caused by a voltage surge and/or faulty components.The reported condition was verified.The burnt smell, unable to start pump because the home position is invalid and ctf (sf2) failed the pump is faulted.To correct the condition, the pump motor driver pca (p/n 6300-0137) will be replaced during refurbishment to prevent future recurrence of pump is in a fault state errors.A device history review revealed no issues that could have caused or contributed to the reported issue.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
• MDR Report Key: 11164693
• MDR Text Key: 230485105
• Report Number: 1416980-2020-08475
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): Y
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup,Followup
• Report Date: 03/19/2021

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: 01/07/2021
• Initial Date Manufacturer Received: 12/23/2020
• Initial Date FDA Received: 01/13/2021
• Supplement Dates Manufacturer Received: 01/14/2021; 03/10/2021
• Supplement Dates FDA Received: 02/03/2021; 03/19/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1