MAUDE Adverse Event Report: BAXTER HEALTHCARE CORP. EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET; SET, I.V, FLUID TRANSFER

Model Number H938173

Device Problem Dull, Blunt (2407)

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

Event Date 04/24/2019

Event Type  Injury  

Event Description

Pharmacy uses baxter exactamix 2400 for tpn compounding.Tech noted at 1530 in the day that the tip on exactamix inlet h938173 had blunted tip and tip appeared to have broken off.All product mixed with machine for the day was discarded and did not reach pts.Pharmacy tech removed mixing set and re-set up compounder with new tubing / sets.No further issues noted.Fda safety report id# (b)(4).

• Brand Name: EXACTAMIX INLET NON-VENTED, HIGH-VOLUME INLET
• Type of Device: SET, I.V, FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORP.
• MDR Report Key: 8582377
• MDR Text Key: 144237761
• Report Number: MW5086379
• 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: 05/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: H938173
• Device Catalogue Number: H938173
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/01/2019
• 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 Outcome(s): Required Intervention