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

Catalog Number	H938743
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/05/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a 5000ml eva (ethyl vinyl acetate) tpn (total parenteral nutrition) bag was leaking.This was further described as ¿once the technician started filling from the bulk bag into the smaller iv (intravenous) bags, they noticed that the 5000ml eva bag was leaking in the area where baxter healthcare name and address is stamped on the bag.¿ this was identified during filling prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: device manufacture date: june 25, 2019 - june 26, 2019.H10: three device was received for evaluation.Unaided visual inspection was performed and observed a defect at the ¿h¿ in baxter healthcare sa fixed print in front of bag.Additional magnified inspection was performed which observed a small hole where the leak and print defect were verified.Functional testing was performed which revealed a leak at the affected area.The reported condition was verified.The cause of the condition could not be determined; however, the most likely cause was due to 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
• 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 ; 2242702068
• MDR Report Key: 12729678
• Report Number: 1416980-2021-06527
• Device Sequence Number: 1479915
• Product Code: LHI
• UDI-Device Identifier: 00085412477275
• UDI-Public: (01)00085412477275
• Combination Product (Y/N): Y
• 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): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/06/2021

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: Other
• Device Expiration Date: 05/31/2022
• Device Catalogue Number: H938743
• Device Lot Number: 60192945
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2021
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/07/2021
• Supplement Date Received by Manufacturer: 11/17/2021
• Initial Report FDA Received Date: 11/01/2021
• Supplement Report FDA Received Date: 12/06/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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