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	Inaccurate Delivery (2339)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2025
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 where it was reported that in ccu, rn arrived for shift and received in hand off that arterial line had been having issues dampening and going flat but would resolve with a flush.Around 21:00 the pump had alarmed several times for increasing pressure, so rn made the decision to change out the transducer.After changing out the transducer the arterial line continued having issues with dampening and again started to alarm for increasing pressure.Around 2240 rn changed transducer again to nicu transducer.After changing the transducer, a second time the line was completely flat and was initially reading the patient's map.Shortly after the pressure began to rise all the way to the 200s.Rn called intensivist to re-wire line.Line was able to be salvaged but required a new dressing.The event date occurred during infusion.The tubing was replaced.Arterial line fluids were used.There was no hole, cut, tears, any crack, disconnection or separation noted.No lot number provided as the packaging was already discarded but sample is available for evaluation.There was patient involvement, no human harm and no delay in therapy reported.
Additional Manufacturer Narrative
The device was received for evaluation.The investigation is pending.
Additional Manufacturer Narrative
The reported complaint of no readings was confirmed on the returned set.No visual anomalies were observed on the returned set.The transducer was electrically tested, and the transducer was not able to be zeroed and could not obtain a reading.The transpac on this set is a vendor manufactured part.The probable cause of the transpac unable to obtain reading had occurred due to a vendor related manufacturing defect from manufacturing.Lot history review could not be conducted because no lot number(s) was/were identified.

• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 22040870
• Report Number: 9617594-2025-01051
• Device Sequence Number: 9280084
• 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): 09/02/2025

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2025
• Supplement Date Received by Manufacturer: 08/06/2025
• Initial Report FDA Received Date: 05/16/2025
• Supplement Report FDA Received Date: 09/02/2025
• 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: UNSPECIFIED PUMP, MFR UNK.
• Patient Sex: Unknown