MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX EM2400 VALVE SET

Model Number H938724

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Patient Involvement (2645)

Event Date 06/12/2014

Event Type  malfunction  

Event Description

On (b)(6) 2014, baxter (b)(4) received medwatch (b)(4) via the united states postal service, 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 documents an incident with our sterile exactamix em2400 valve set (part# h938724, lot# 790364).According to mw (b)(4), on (b)(6) 2014, the initial reporter found an exactamix valve set leaking ingredient from valve port #4.Upon inspection by the customer, the valve core was rotated out of the home position, in a counterclockwise direction, and the side of the port facing the outside wall of the housing was pinched inward.The report indicates no patient involvement resulted from this incident.Baxter (b)(4) is currently making attempts to have the device returned for a detailed quality inspection.

Manufacturer Narrative

This issue cannot be confirmed, as no product has yet been returned for evaluation.(b)(4) has been created to retrieve the device for inspection, and the customer has been provided with a return shipping label.However, the device has not been returned at this time.If the device is made available for evaluation, a follow-up report will be submitted.This complaint, as reported by the user facility, does not indicate patient or operator involvement.As the reported failure would be unlikely to cause 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 information is reported to us via medwatch report.Evaluation codes: method - n/a, not applicable.Results - none.Conclusions - device not returned.

Manufacturer Narrative

The customer returned a companion sample for evaluation, however, it was not the actual sample reported in the complaint.The provided sample was found to operate as designed.The root cause of the reported issue remains unknown at this time.Evaluation codes: method - actual device not evaluated; results - device performed according to specification; method - unable to confirm complaint.

• Brand Name: EXACTAMIX EM2400 VALVE SET
• Type of Device: VALVE SET
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; 9540 s. maroon circle, ste 400; englewood CO 80112
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION; 14445 grasslands drive; englewood CO 80112
• Manufacturer Contact: eric cops ; 9540 s. maroon circle, ste 400; englewood, CO 80112 ; 3033909774
• MDR Report Key: 4034820
• MDR Text Key: 4882227
• Report Number: 1419106-2014-00007
• 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: Other
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

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: Pharmacist
• Device Expiration Date: 12/31/2016
• Device Model Number: H938724
• Device Lot Number: 790364
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2014
• Initial Date FDA Received: 08/25/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/24/2014
• 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