MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION VALVE SET, EMIX 2400 (724); VALVE SET 724

Catalog Number H938724

Device Problem Free or Unrestricted Flow (2945)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/26/2015

Event Type  malfunction  

Manufacturer Narrative

As the lot number of this device was not provided, a manufacturing review could not be performed.However, the sample was received for evaluation.The reported event was verified.Visual and magnified inspection revealed a bent and damaged valve set core #4 (corresponding to port #4 on the exactamix compounder) and during functional testing, an occlusion alarm was triggered.Based on the damage noted during visual and magnified inspection, it was determined the event was caused by the device being improperly installed onto the compounder, which damaged the valve set core and led to the reported problem.The exactmix compounder operator manual details the proper procedure for installing valve sets onto the compounder.This event is logged under cfn-(b)(4).

Event Description

During troubleshooting with baxter technical support concerning an occlusion test failure, the customer noted bubbles rising in the sodium acetate vial connected to port 4 of an em2400 valve set.Upon further inspection, the customer noted port 4 appeared to remain open while other ingredients on different ports were being pumped, indicating sodium acetate may have been over delivered into bags produced with this valve set.The valve set was replaced to correct the issue.The customer determined two tpn bags had been produced using the faulty valve set and that one of these bags had been used for patient infusion.However, no patient injury, adverse event, or need for medical intervention was reported.The second bag was discarded before patient use.No additional information is available.

• Brand Name: VALVE SET, EMIX 2400 (724)
• Type of Device: VALVE SET 724
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: tracey hughes ; 9540 maroon circle; suite 400; englewood, CO 80112 ; 3033909898
• MDR Report Key: 5098759
• MDR Text Key: 26598481
• Report Number: 1419106-2015-00241
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K002705
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Report Date: 09/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Pharmacist
• Device Catalogue Number: H938724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/26/2015
• 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: N
• Patient Sequence Number: 1
• Treatment: TPN
• Patient Age: 2 DA
• Patient Weight: 2