MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION TUBE SET, STD VOL, UNIV ENDS,; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Catalog Number	H93821
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/28/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that four (4) fluid transfer tube sets were leaking.This event occurred during filling.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
H4: the lot was manufactured between april 07, 2022 and april 08, 2022.H10: two (2) actual devices were received for evaluation.The remaining 2 samples were not received, therefore a device analysis could not be completed for those samples.Unaided visual inspection using the naked eye along with magnification was performed on the returned samples which identified a tear/hole at a damaged area (midsection) of the silicone tubing of both tube sets.A repeater pump system level testing was performed which revealed a leak from the impacted areas.The reported condition was verified on the returned samples.The cause of the damage could not be determined; however a probable cause is due to customer handling during setup causing damage to the section of tubing from the repeater pump rotor.Instructions for use does state to¿move the rotor back and forth several times to make sure that it moves freely.¿ 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: TUBE SET, STD VOL, UNIV ENDS,
• Common Device Name: SYSTEM/DEVICE, PHARMACY COMPOUNDING
• 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: 16765371
• Report Number: 1416980-2023-01835
• Device Sequence Number: 6106077
• Product Code: NEP
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/24/2023

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: 03/31/2025
• Device Catalogue Number: H93821
• Device Lot Number: 60359403
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/27/2023
• Supplement Date Received by Manufacturer: 05/23/2023
• Initial Report FDA Received Date: 04/18/2023
• Supplement Report FDA Received Date: 05/24/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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