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, MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Model Number	42800-03
Medical Device Problem Code	High Readings (2459)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/12/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been requested from the customer for evaluation.However, it has not yet been received.
Event or Problem Description
The event involved a transpac¿ it monitoring kit, 60" pressure tubing, 3ml flush device, macrodrip.The reporter stated that the transducer looked like it had a wrong calibration when it was calibrated correctly.The device was reading a high pressure (280/170), but the blood pressure cuff on the patient was reading approximately 120 systolic.The waveform was good.It looked like it was not calibrated, but it had just been calibrated.The patient was treated with anesthetic and esmolol based on the high pressure readings.The provider set up another arterial line and put it on the patient.The readings on the new line correlated with the blood pressure cuff.There was patient involvement, but no harm was reported.This is the first of two reported events.
Additional Manufacturer Narrative
The reported complaint of inaccurate readings was not confirmed.No sample or videos were returned.However an image was provided by the customer showing the label of the product.A failure mode was not able to be identified from the image provided by the customer.Without the return of the reported sample, a probable cause cannot be identified.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.D9: sample availability was changed from "yes" to "no" as customer did not return sample for evaluation.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" PRESSURE TUBING, 3ML FLUSH DEVICE, MACRODRIP
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16086122
• Report Number: 9617594-2023-00003
• Device Sequence Number: 2009479
• Product Code: DRS
• UDI-Device Identifier: 00887709097582
• UDI-Public: (01)00887709097582(17)250801(10)8035027
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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 Expiration Date: 08/01/2025
• Device Model Number: 42800-03
• Device Catalogue Number: 42800-03
• Device Lot Number: 8035027
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2022
• Supplement Date Received by Manufacturer: 01/18/2023
• Initial Report FDA Received Date: 01/03/2023
• Supplement Report FDA Received Date: 01/23/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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: ESMOLOL, UNK MFR
• Patient Sex: Unknown