MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF; INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES

Catalog Number 011-46115-21

Device Problems Disconnection (1171); Separation Failure (2547)

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

Event Date 05/19/2022

Event Type  malfunction  

Event Description

The event involved a transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port.It was reported that the safeset became loose and disconnected between the reservoir and the line going to the patient (the diluent set was disconnected from the two way valve).It appeared that the adhesive hadn¿t stuck and adhesive was observed at the point of disconnection.The safeset was replaced with a new one that was not loose and did not appear that it would come apart in the same area.The number of hours the device was used was 0.1.No medication was being used with the product.There was no leakage.Although there was a delay in therapy, there was patient involvement and no human harm.This captures the first of two events reported.

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.The customer identified 3 possible lot numbers (plots): 5201049 (expiry date 02/01/2024, mfr date 03/01/2021).5254594 (expiry date 04/01/2024, mfr date 05/01/2021).5487785 (expiry date 07/01/2024, mfr date 12/01/2020).

Manufacturer Narrative

The complaint of separation can be confirmed on the returned used list #011-46115-21, transpac® iv monitoring kit w/03 ml squeeze flush device, microclave®, 03 ml safeset¿ reservoir and blood sampling port; lot #unknown.As received, the stopcock was separated from the base of the barrel reservoir.The area of the separation was examined.There was adhesive observed on the base of the barrel reservoir.However, the observed adhesive was tacky.The probable cause of the separation observed is due to uv adhesive not being fully cured during the manual assembly process during manufacturing.D9 - date returned to mfg: 7/7/2022.Additional entries can be found in a5, a6 and h6 (component code).

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH DEVICE, MICROCLAVE®, 03 ML SAF
• Type of Device: INVASIVE BLOOD PRESSURE MONITORING DISPOSABLES
• 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: 14713748
• MDR Text Key: 294172604
• Report Number: 9617594-2022-00175
• Device Sequence Number: 1
• Product Code: DRS
• 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: 05/19/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: 011-46115-21
• Device Lot Number: PLOTS
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/19/2022
• Initial Date FDA Received: 06/16/2022
• Supplement Dates Manufacturer Received: 07/27/2022
• Supplement Dates FDA Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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: HEPARIN SODIUM 0.45% SODIUM CHLORIDE, MFR UNK