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	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.Plots: (b)(6) mfr date: 2/1/2024 exp date: 2/1/2027.(b)(6) mfr date: 4/1/2024 exp date: 3/1/2027.(b)(6) mfr date: 9/1/2024 exp date: 9/1/2027.
Event or Problem Description
The event occurred on various days in (b)(6) 2024 and involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip.The reporter stated that they had a couple arterial lines that were significantly dampened.It was also stated that it required interventions (rewiring) for both of these arterial lines that had issues with transducers.These reported transducers were changed on (b)(6) 2024 and also changed two transducers today that were having issues.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 kid's kits, but this is not a recent change in practice.Hence, there was no human harm reported.This captures 2 occurrences.
Additional Manufacturer Narrative
The reported complaint of dampening was not confirmed during the complaint investigation.No visual anomalies were observed on the returned used and partial list #42801-03, transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip.When the returned device was tested for dampening/coefficient test, the damping coefficient and the natural frequency fell within the acceptable range and passed the investigation testing.The possible lot numbers were reviewed, no nonconformities were identified that may have contributed to the reported complaint.Corrected information can be found in d10 concomitant product.

• 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: 21148982
• Report Number: 9617594-2025-00087
• Device Sequence Number: 9098043
• 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): 03/11/2025

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: 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: 02/11/2025
• Initial Report FDA Received Date: 01/14/2025
• Supplement Report FDA Received Date: 03/11/2025
• 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, MFR UNK.; ARTERIAL LINE FLUID.; MEDFUSION 4000 SYRINGE PUMPS.; MEDFUSION 4000 SYRINGE PUMPS.; UNSPECIFIED ARTERIAL LINE, MFR UNK.
• Patient Sex: Unknown