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

Catalog Number H938737

Device Problem Fluid/Blood Leak (1250)

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

Event Date 12/06/2023

Event Type  malfunction  

Event Description

It was reported that a 250ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag leaked from central port during filling.There was no patient involvement.No additional information is available.

Manufacturer Narrative

(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

H4: the lot was manufactured from october 24, 2022 to october 25, 2022.H10: the device was received for evaluation.A visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional leak testing was performed using tap water to fill the container, and a leak was observed at the spike port bonding area of the sample.The reported condition was verified.The cause of the condition could not be determined; however, the cause was most likely due to an inadequate or a lack of cyclohexanone application to the spike port connector when it was inserted to the spike port during the manufacturing process.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.

• 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: 18416349
• MDR Text Key: 331581291
• Report Number: 1416980-2023-06800
• Device Sequence Number: 1
• Product Code: LHI
• UDI-Device Identifier: 00085412477213
• UDI-Public: (01)00085412477213
• Combination Product (y/n): N
• Reporter Country Code: HK
• PMA/PMN Number: K900585
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 01/25/2024

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: H938737
• Device Lot Number: 60407093
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/23/2024
• Supplement Dates FDA Received: 01/25/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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