MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, UN-BONDED MA; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-03
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip.The reporter stated that they had several instances of increasing pressure alarms which means that the fluid was not infusing properly through the transducer.It was also stated that the increase pressure alarms were resolved after pulling the ¿blue tab¿ on the transducer, which makes the fluid unable to pass through the transducer properly.Status was during infusion.The fluid that used was arterial line fluid.It was also stated that all of these transducers were utilizing arterial line fluid running at 1-2 ml/hr on a syringe pump.All of these had 30ml syringes running on medfusion 4000 syringe pumps.The pressure bar on the syringe pump will decrease if the blue tab on the transducer is pulled which is why their clinicians thought that it has something to do with the fluid moving through the transducer.This seems to be occurring on night 2-3 of the transducer being used and switched out every 4 days/ 96 hours.They attach their transducers to kids kits, but this is not a recent change in practice.Hence, there was no human harm reported.
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.Plots: 13903526 mfr date: 2/1/2024 exp date: 2/1/2027.13937379 mfr date: 4/1/2024 exp date: 3/1/2027.14128058 mfr date: 9/1/2024 exp date: 9/1/2027.
Additional Manufacturer Narrative
The reported complaint of increasing pressure alarms was 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 transpac it set was tested for continuous flow rate, when the pull flush is in an inactivated state, the sample failed to meet specification requirements.The dfu specifies that a 30 ml transpac it set must be used with a pump.The 3 ml set is not intended for use with infusion pumps.The probable cause of the increased pressure alarm had occurred due to the use of a 3 ml transpac it set in a pump application, contrary to its intended use.The possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" 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. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 21148992
• Report Number: 9617594-2025-00088
• Device Sequence Number: 21141304
• Product Code: DRS
• UDI-Device Identifier: 00887709120655
• UDI-Public: 00887709120655
• 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,Followup
• Report Date (Section B): 10/01/2025

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: 42801-03
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/17/2024
• Supplement Date Received by Manufacturer: 07/14/2024
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: ARTERIAL LINE FLUID.; MEDFUSION 4000 SYRINGE PUMPS.
• Patient Sex: Unknown