MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-05
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/21/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following was returned for complaint investigation: -one used partial list# 42801-05, transpac¿ it monitoring kit, 84" pressure tubing, 3ml flush device, un-bonded macrodrip; lot# unknown.The issue of 'increasing pressure alarms' was not confirmed.No visual anomalies were observed.When the transpac was electrically tested, and a wave form was able to be zeroed with the waveform visible on the monitor.The transducer was tested for 1 hour and was able to obtain a reading.When the sample was tested for a continuous flow rate when the squeeze flush is in an inactivated state, the sample passed the continuous flow rate.The product had performed per the specifications.A review of the device history record is pending at this time.A supplemental emdr will be submitted when it becomes available.
Event or Problem Description
The complaint/event involved a transpac¿ it monitoring kit, 84" pressure tubing, 3ml flush device, un-bonded macrodrip that reportedly generated an arterial line dampened waveform during infusion.There was no human harm associated with this reported complaint/event.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 84" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA
• 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: 22022761
• Report Number: 9617594-2025-01001
• Device Sequence Number: 15648088
• Product Code: DRS
• UDI-Device Identifier: 00887709120679
• UDI-Public: (01)00887709120679(17)270301(10)13937379
• Combination Product (Y/N): N
• Initial Reporter State: NE
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 05/14/2025

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: 42801-05
• Device Lot Number: 13937379
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/15/2025
• Initial Report FDA Received Date: 05/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: UNSPECIFIED ARTERIAL LINE, MFR UNK
• Patient Sex: Unknown