MAUDE Adverse Event Report: BAXTER HEALTHCARE - ENGLEWOOD EM 2400, MAIN MODULE; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number 2400M

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Patient Involvement (2645)

Event Date 02/05/2018

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the screws on the door of an exactamix 2400 main module were loose.It was not specified when in the process this occurred.There was no patient involvement.No additional information is available.

Manufacturer Narrative

The device was received for evaluation and the evaluation is complete.Hi-pot and wet functional tests were performed with no issues or errors and all tests passed.A visual inspection of the device was performed using an unaided naked eye.During the visual inspection, it was found that the pump cover was loose and that loctite had not been applied to the shoulder bolt.The reported issue was verified.The cause of the condition was determined to the absence of loctite during the assembly process of manufacturing.To correct the condition, the shoulder bolt would be replaced, and loctite applied.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, MAIN MODULE
• Type of Device: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• Manufacturer (Section D): BAXTER HEALTHCARE - ENGLEWOOD; englewood CO
• Manufacturer (Section G): BAXTER HEALTHCARE - ENGLEWOOD; 14445 grasslands dr; englewood CO 80112
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7286273
• MDR Text Key: 100660401
• Report Number: 1416980-2018-00930
• Device Sequence Number: 1
• Product Code: NEP
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/05/2018

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: 2400M
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/23/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/05/2018
• Initial Date FDA Received: 02/21/2018
• Supplement Dates Manufacturer Received: 03/21/2018
• Supplement Dates FDA Received: 04/05/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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