MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. BIFURCATED TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML SQUEEZE FLUSH; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-46107-17

Device Problem Unable to Obtain Readings (1516)

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

Event Date 02/20/2022

Event Type  malfunction  

Manufacturer Narrative

The device was reported to have been discarded.Without the returned device a probable cause is unable to be determined.

Event Description

It was reported that after a few hours of use the arterial line tracing got flat on the cardiac monitor and the monitor did not allow to zero the pressures displaying an "excessive offset" error.The monitoring cable was changed, and the device was attempted to zero again but it did not work.The arterial line transducer set was changed, and the problem was resolved.There was patient involvement with no harm reported.No additional information is available.

• Brand Name: BIFURCATED TRANSPAC® IV MONITORING KIT W/SAFESET¿ RESERVOIR, 03 ML SQUEEZE FLUSH
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 13793992
• MDR Text Key: 290945718
• Report Number: 9617594-2022-00054
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619060190
• UDI-Public: (01)00840619060190(17)230801(10)4981425
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K061573
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/17/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/01/2023
• Device Catalogue Number: 011-46107-17
• Device Lot Number: 4981425
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2020
• 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