MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. ARTERIAL TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, 72" (183 CM) RED STRI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46112-72

Device Problems Incorrect, Inadequate or Imprecise Result or Readings (1535); Failure to Zero (1683)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/30/2023

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation; however, testing has not yet been completed.

Event Description

The complaint/event involved a arterial transpac® it monitoring kit w/03 ml flush device, 72" (183 cm) red stripe pt and 10" (25 cm) red stripe pt extension and 1 needleless valve.It was reported that the diastolic reading from the device was different (very low) compared to the non-invasive blood pressure (nibp) reading (150/20).The art (arterial) line did not zero and displayed a pressure high with "+++".They became aware of the issue when the customer tested the product and identified that it was not working as it should be.There was no medication involved.The biomed checked the device and tried changing the cables with no success.The customer stated that this complaint/issue could be an infection risk hazard if it had been attached to a patient.There was no patient involvement, no delay in therapy and no patient harm.

Manufacturer Narrative

The following was returned by the customer for investigation: one used list #011-46112-72, arterial transpac® it monitoring kit w/03 ml flush device, 72" (183 cm) red stripe pt and 10" (25 cm) red stripe pt extension and 1 needleless valve; lot #13612940.The customer's reported issue of 'unable to obtain a reading' was confirmed.Images were provided by the customer showing readings on the monitor and the involved device in a plastic bag.No visual anomalies were observed on the returned set.The transducer was electrically tested and the transducer was able to be zeroed but could not obtain a reading.The set was primed and pressure leak tested and no leaks were observed.The probable cause of the transpac unable to obtain a reading had occurred due to a manufacturing defect.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: ARTERIAL TRANSPAC® IT MONITORING KIT W/03 ML FLUSH DEVICE, 72" (183 CM) RED STRI
• Type of Device: 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: 18212625
• MDR Text Key: 330019875
• Report Number: 9617594-2023-01032
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619079253
• UDI-Public: (01)00840619079253(17)260401(10)13612940
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/07/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-46112-72
• Device Lot Number: 13612940
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: UNSPEC. NON-INVAS. BLD PRESS. (NIBP) CUFF, MFR UNK