MAUDE Adverse Event Report: THE METRIX COMPANY EXACTAMIX; 3000 ML EMPTY EVA DUAL CHAMBER BAG

Model Number	H938905
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be filed.
Event or Problem Description
It was reported that a patient's mother called the hospital to report that parenteral nutrition solution was leaking between the chambers of an exactamix 3000 ml dual chamber eva bag.This was identified at the patient's home prior to use.It was further reported that the patient noticed the leak before activating the dual chamber bag and that the lipid from the top chamber was leaking into the bottom chamber.It is unclear if the bag was partially activated already, or if there was an issue with the seal between the two chambers.As the leak was between the chambers, no parenteral nutrition solution spilled from the bag to the outside environment.There was no mention of the condition of the dividing rod or whether it was placed correctly.After noticing the leak, the patient activated the bag and then discarded it.No photographs have been provided.There was no report of patient injury or medical intervention as a result of this event.No additional information is available.

• Brand Name: EXACTAMIX
• Common Device Name: 3000 ML EMPTY EVA DUAL CHAMBER BAG
• Manufacturer (Section D): THE METRIX COMPANY; 4400 chavenelle road; dubuque IA 52002
• MDR Report Key: 11982825
• Report Number: 1937141-2021-00010
• Device Sequence Number: 3502848
• Product Code: KPE
• UDI-Device Identifier: 00085412477473
• UDI-Public: 00085412477473
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K960581
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2021

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
• Operator of Device: Lay User/Patient
• Device Expiration Date: 11/27/2025
• Device Model Number: H938905
• Device Catalogue Number: H938905
• Device Lot Number: 63630-A5971
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2021
• Initial Report FDA Received Date: 06/11/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1