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	02/17/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Although the multiple attempts were requested for the device to be returned for evaluation, it has not yet been received.
Event or Problem Description
The complaint/event involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, un-bonded macrodrip.The reporter stated that, in the picu, the patient's arterial line was not consistently measuring and would frequently flatten or dampen on the patient's monitor during an infusion of fluids.This prevented staff from obtaining accurate arterial blood pressure (abp) readings on a patient who was on continuous antihypertensive medication at the time.The transducer was originally on a syringe pump but was switched over to a pressure bag overnight due to pressure alarming/pump issues.The arterial line continued to have issues after switching to a pressure bag.The tubing was replaced.There was no hole, cut, tears, any crack, disconnection or separation noted.There was no human harm and no delay in therapy reported.
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: 22030207
• Report Number: 9617594-2025-01010
• Device Sequence Number: 12799848
• 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: 05/15/2025
• 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: PRESSURIZED BAG, MFR UNK.; UNSPECIFIED FLUIDS, MFR UNK.; UNSPECIFIED PATIENT MONITOR, MFR UNK.; UNSPECIFIED SYRINGE PUMP, MFR UNK.
• Patient Sex: Unknown