MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EVA BAG

Model Number 739

Device Problem Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Patient Involvement (2645)

Event Date 05/13/2014

Event Type  malfunction  

Event Description

On (b)(4) 2014, baxter (b)(4) received (b)(4), with a postmark date of (b)(4) 2014.Per our local procedure.Baxter (b)(4) will use the postmark date as our aware date.The medwatch reports that on (b)(6) 2014, staff at (b)(6), found an exactamix bag (part# 739, lot# 785624) with the ports sealed to the outside of the bag.This product is a sterile eva (ethyl vinyl acetate) bag used in the delivery of total parenteral nutrition.With a large-bore threaded fill port connector, the bag is safe for 3-in-1 compounding.As the medwatch report indicates that the ports were found attached to the outside of the bag, the product was unusable; therefore, there was no pt involvement.The product has been discarded by the user facility, and is no longer available for a return inspection.

Manufacturer Narrative

The reported issue cannot be confirmed, as no product has been returned for eval.Although we are unable to confirm this complaint, this issue has been previously investigated under a nonconformance investigation, which led to the implementation of corrective action.This complaint, as reported by the user facility, does not indicate pt or operator involvement.As the reported failure poses to risks that would cause or contribute to death or serious injury, an mdr would not typically have been submitted for this event.However, our local procedure requires us to file when the info is reported to us via medwatch report.

• Brand Name: EXACTAMIX EVA BAG
• Type of Device: EXACTAMIX EVA BAG
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle ste 400; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands dr.; englewood CO 80112 706
• Manufacturer Contact: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 3947053
• MDR Text Key: 14878070
• Report Number: 1419106-2014-00004
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 07/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 739
• Device Lot Number: 785624
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/09/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 07/31/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1