MAUDE Adverse Event Report: BAXTER EXACTAMIX BAG

Model Number H938741

Device Problem Material Rupture (1546)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/08/2018

Event Type  malfunction  

Event Description

Tpn bag was pumped and air removed.Tech was adding tubing and bag ruptured along the top seam.Baxter item # h938741, lot 60066290.Bags have been sequestered.

• Brand Name: EXACTAMIX BAG
• Type of Device: EXACTAMIX BAG
• Manufacturer (Section D): BAXTER
• MDR Report Key: 7352146
• MDR Text Key: 103004568
• Report Number: MW5075944
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 03/15/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2020
• Device Model Number: H938741
• Device Lot Number: 60066290
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2018
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 63 YR
• Patient Weight: 41