MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV DISPOSABLE MONITORING KIT W/BONDED STOPCOCK, SELF-RETAINING CAP AND; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46114-74
Medical Device Problem Code	Device Sensing Problem (2917)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending completion.Upon completion a supplemental mdr will be submitted.
Event or Problem Description
A complaint was received regarding a transpac® iv disposable monitoring kit w/bonded stopcock, self-retaining cap and 30 ml squeeze flush device that experienced device inaccuracy.It was stated that the nicu rn reported that transducer will not give a consistent reading for a-line bp.The device zeroed multiple times, then cable changed out, and multiple nurses attempted to trouble shoot problem.The monitor will only consistently give number in parathesis but not actual bp reading.Uac is new this am, patent when flushed, and it does draw back.The event date occurred 12-jun-2025 at 1:58 pm.The sample is available for evaluation.There was patient involvement, no human harm and unknown delay in therapy reported.
Additional Manufacturer Narrative
Correction: d9 - device available for evaluation - no.Investigation summary: the complaint could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the used sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC® IV DISPOSABLE MONITORING KIT W/BONDED STOPCOCK, SELF-RETAINING CAP AND
• Common Device Name: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22487789
• Report Number: 9617594-2025-01443
• Device Sequence Number: 8016064
• Product Code: DRS
• UDI-Device Identifier: 00887709080171
• UDI-Public: (01)00887709080171(17)271101(10)14197637
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/11/2025

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: Health Professional
• Device Catalogue Number: 46114-74
• Device Lot Number: 14197637
• 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: 06/13/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 07/11/2025
• Supplement Report FDA Received Date: 08/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/04/2024
• 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