MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX; SET, I.V. FLUID TRANSFER

Model Number	H938743
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
B3: the event occurred during an unspecified day of june 2024.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that ten (10) exactamix 5000 ml eva (ethylene vinyl acetate) tpn (total parenteral nutrition) bags leaked from the middle/ brown port prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H11: three (3) devices were received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, and a leak from the administration spike port bonding area on all three of the returned samples was observed.The reported condition was verified.The cause of the condition could not be determined.The likely cause of the leak of the leak may be from inadequate or lack of cyclohexanone being applied to the spike port connector when it was inserted into the spike port tubing.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H11: a nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: EXACTAMIX
• Common Device Name: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): AVAILMED; c. industrial lt. 001 mz. 105; no 20905 int a, col cd ind.; tijuana, baja california 22444 ; MX 22444
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 19633129
• Report Number: 1416980-2024-03279
• Device Sequence Number: 7437212
• Product Code: LHI
• UDI-Device Identifier: 00085412477275
• UDI-Public: (01)00085412477275(10)60462413(17)260430
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K900585
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/16/2024

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: Other
• Device Expiration Date: 04/30/2026
• Device Model Number: H938743
• Device Catalogue Number: H938743
• Device Lot Number: 60462413
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/04/2024
• Supplement Date Received by Manufacturer: 08/29/2024; 09/23/2024
• Initial Report FDA Received Date: 06/28/2024
• Supplement Report FDA Received Date: 09/06/2024; 10/16/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/11/2023
• 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
• Patient Sex: Unknown