MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION 5L EFFLUENT BAG; SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES

Catalog Number	114423
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	06/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This event was received through medwatch: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 5 l effluent bag was observed to be leaking during continuous renal replacement therapy (crrt).Therapy was being performed with a prismaflex machine via extracorporeal membrane oxygenation (ecmo), connected with a prismaflex set.It was reported that upon changing the effluent bag, the right atrial pressure started to decrease to negative numbers, the ecmo circuit was cutting out and the venous negative pressure from ecmo became too negative and the patient flow from ecmo decreased.The patient became hypotensive and was treated with a bolus of 60 ml of normal saline.The effluent bag was observed to be leaking in spite of the outlet valve being completely closed.A new bag was used to continue with therapy.No additional information is available.
Additional Manufacturer Narrative
H10: a batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: 5L EFFLUENT BAG
• Common Device Name: SYSTEM, HEMODIALYSIS, REMOTE ACCESSORIES
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ECM - THE METRIX COMPANY - SP015606; 4400 chavenelle road; dubuque IA 52002
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15162667
• Report Number: 1416980-2022-04039
• Device Sequence Number: 17618820
• Product Code: MON
• UDI-Device Identifier: 07332414112264
• UDI-Public: (01)07332414112264
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 07/15/2024
• Device Catalogue Number: 114423
• Device Lot Number: 3570-A7344
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2022
• Supplement Date Received by Manufacturer: 08/05/2022
• Initial Report FDA Received Date: 08/04/2022
• Supplement Report FDA Received Date: 08/31/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PRISMAFLEX MACHINE; PRISMAFLEX SET
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 6 MO
• Patient Sex: Male