MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP; SET, I.V. FLUID TRANSFER

Catalog Number H938738

Device Problems Break (1069); Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

H10: the device was received for evaluation.During visual inspection, damage was observed at one end where the valve set snaps on to the main module of valve set.The set underwent functional testing by removing the spike port cover and a leak was noted at the spike port membrane.The reported condition was verified.The cause of the condition could not be determined.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.

Event Description

During evaluation one exactamix 500 ml eva (ethylene-vinyl acetate) tpn (total parenteral nutrition) bag leaked at the spike port membrane.Upon further inspection, damage was noted to one end where the valve set snaps on to the main module of valve set sample.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Correction: g3: date received by mfr - the initial mdr g3 date was inadvertently submitted as (b)(6)2024; however, the correct date is (b)(6)2024.

• Brand Name: EXACTAMIX TUBING SETS FOR BAXA EXACTA-MED PHARMACY PUMP
• Type of Device: 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: 18933387
• MDR Text Key: 338080000
• Report Number: 1416980-2024-01203
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477220
• UDI-Public: (01)00085412477220
• Combination Product (y/n): N
• Reporter Country Code: KS
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/25/2024

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
• Device Operator: Other
• Device Catalogue Number: H938738
• Device Lot Number: 60405582
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/15/2024
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/15/2024
• Initial Date FDA Received: 03/19/2024
• Supplement Dates Manufacturer Received: 03/25/2024
• Supplement Dates FDA Received: 03/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/23/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1