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

Catalog Number 2400B

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Date 09/01/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the feet were broken on an exactamix base plate module and it would not sit flat on the hood.It was not specified when in the process this occurred.There was no patient involved.No additional information is available.

Manufacturer Narrative

The device was returned and evaluated for the reported issue of broken baseplate feet that would not sit flat.A visual inspection was completed and found that the base plate feet support brackets were bent, loose, and missing vinyl caps.The reported condition was verified.The cause of the damage could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EM 2400, BASE PLATE 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: 6883981
• MDR Text Key: 87394206
• Report Number: 1416980-2017-07722
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 02/02/2018

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: 2400B
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/01/2017
• Initial Date FDA Received: 09/21/2017
• Supplement Dates Manufacturer Received: 01/29/2018
• Supplement Dates FDA Received: 02/02/2018
• 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