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 complaint of high reading was not confirmed on the returned set.An image was provided by the customer showing the involved product.No visual anomalies were observed on the returned set.When the transpac was electrically tested, and a wave form was able to be zeroed with the waveform visible on the monitor.The sample had performed per the specifications.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.
Event or Problem Description
The event involved a transpac¿ it monitoring kit neonatal, 12", 3 stopcocks, 30ml flush (for use with infusion pump).The reporter stated that the product was involved in a patient safety report in the facility.The issue was that the iv tubing was bent causing an alarm for high pressure.The waveform was dampened or would read as disconnected and would cause alarms to go off.There was patient involvement and there was delay in therapy; however, there was no human harm.

• 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: 20752410
• Report Number: 9617594-2024-01628
• Device Sequence Number: 8004843
• 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): 11/22/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/28/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 11/21/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED PATIENT MONITOR, MFR UNK.
• Patient Sex: Unknown