MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42800-23
Medical Device Problem Codes	Deformation Due to Compressive Stress (2889); Inaccurate Information (4051)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/29/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.The investigation is pending.
Event or Problem Description
The event involved a transpac¿ it monitoring kit neonatal, 12", 3 stopcocks, 30ml flush (for use with infusion pump) where the reporter stated that the iv tubing is bent causing an alarm for high pressure.It was stated that when they tried to zero the line, the waveform was dampened or would read as disconnected.It would cause alarms to go off.After troubleshooting with a flex nurse, they noticed that the line entering the transducer was compressed down.They straightened the iv tubing connecting to the transducer and got an accurate reading, however as soon as released the tubing again was faced with the same alarms and dampened wave form.There was patient involvement, and no human harm reported.
Additional Manufacturer Narrative
The reported complaint could not be confirmed.No product samples, or videos were returned for investigation.However, an image was provided by the customer showing the involved device.A failure mode was not able to be identified from the image provided.The device history review (dhr) for lot 13732239 was reviewed and no non-conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT NEONATAL, 12", 3 STOPCOCKS, 30ML FLUSH (FOR USE WITH
• 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: 20684408
• Report Number: 9617594-2024-01607
• Device Sequence Number: 20640442
• Product Code: DRS
• UDI-Device Identifier: 00887709097964
• UDI-Public: (01)00887709097964(17)260801(10)13732239
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/18/2024

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: 42800-23
• Device Lot Number: 13732239
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: 11/20/2024
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2023
• 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