MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-42584-05

Device Problem Incorrect, Inadequate or Imprecise Result or Readings (1535)

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

Event Date 03/28/2022

Event Type  malfunction  

Event Description

The event involved a transpac® iv monitoring kit, disposable transducer, 3 ml squeeze flush, macrodrip.The customer stated while this device was being used on the patient, there was inconsistency of pa and nibp values.The inconsistency of the pa and nibp values: 2 to 4 points compared to the nibp with correct curve.The drug involved was a physiological serum.There was no physical defect noted on the device.There was a one hour delay in therapy.There was no report of blood loss.The customer stated that the therapy was not completed, therefore the medical intervention provided was changing the sensor.The patient's condition before, during and after the incident remained the same.There was a delay in therapy and patient involvement, however no report of patient harm.Additional information was received on may 24th from the customer stating there was 4 occurrences.This captures 2 out of the 4 occurrences.

Manufacturer Narrative

The customer has lost the sample so there was no product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.Additional information was received by the customer 5/24/2022 updating the occurrences from 1 to 4.Based on the updated occurrences the due date for this report is 6/23/2022.

• Brand Name: TRANSPAC® IV MONITORING KIT, DISPOSABLE TRANSDUCER, 3 ML SQUEEZE FLUSH, MACRODRI
• 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: 14691683
• MDR Text Key: 303238550
• Report Number: 9617594-2022-00168
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619037017
• UDI-Public: (01)00840619037017(17)230101(10)4605999
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/15/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2023
• Device Catalogue Number: 011-42584-05
• Device Lot Number: 4605999
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2020
• 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
• Treatment: UNSPECIFIED DEVICE MFR PRODIMED LOT # 50048517; UNSPECIFIED PHYSIOLOGICAL SERUM, UNK MFR