MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION REPEATER; SYSTEM/DEVICE, PHARMACY COMPOUNDING

Model Number	H93821
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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 foreign matter contamination was observed in the tubing of three (3) repeater pump fluid transfer tube sets.This issue was further described as, ¿particles were found to be present at the thicker end of the ll tube (as if mixing small pieces of plastic and dust)¿ and ¿the first hose had the most, the second fewer, but bigger nuggets, and the third had quite a few¿.This issue was discovered during handling prior to patient use.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Correction: b5.B5: remove reference to "patient".Device is used in pharmacy operations.H4: the lot was manufactured between june 14-19, 2023.H11: the actual devices were not available; however, two photographs and a companion sample were provided for evaluation.Visual inspection was performed on all samples; a particle of foreign matter was identified on the tubing of the companion sample and there was evidence of particles on the photographs of an actual sample.The reported condition was verified.The cause of the issue could not be determined; however, the cause was most likely inherent to contamination during the manufacturing packaging 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: REPEATER
• 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: 19577231
• Report Number: 1416980-2024-03085
• Device Sequence Number: 4056902
• Product Code: NEP
• UDI-Device Identifier: 00085412476520
• UDI-Public: (01)00085412476520(10)60470440(17)260531
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2025

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: 05/31/2026
• Device Model Number: H93821
• Device Catalogue Number: H93821
• Device Lot Number: 60470440
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2024
• Supplement Date Received by Manufacturer: 04/22/2025
• Initial Report FDA Received Date: 06/20/2024
• Supplement Report FDA Received Date: 05/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NA.
• Patient Sex: Unknown