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

Catalog Number EXACTAM

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 04/20/2022

Event Type  malfunction  

Event Description

It was reported that the power cable of an exactamix main module was damaged; the cable was pinched with exposed wires.This was observed during power up in the pharmacy.The power cable was replaced.There was no patient involvement and no operator injury.No additional information is available.

Manufacturer Narrative

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

Manufacturer Narrative

H10: the device was not returned; therefore, a device analysis could not be completed.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 ; 2242702068
• MDR Report Key: 14409022
• MDR Text Key: 291736675
• Report Number: 1416980-2022-02450
• Device Sequence Number: 1
• Product Code: NEP
• UDI-Device Identifier: 05413765570131
• UDI-Public: (01)05413765570131
• 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: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/30/2022

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: Health Professional
• Device Catalogue Number: EXACTAM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/20/2022
• Initial Date FDA Received: 05/16/2022
• Supplement Dates Manufacturer Received: 09/26/2022
• Supplement Dates FDA Received: 09/30/2022
• 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