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 prior to connection to the patient and after the line was primed, the safeset became loose and disconnected between the reservoir and the line.The diluent set was disconnected from the two way valve and it appeared that the adhesive hasn¿t stuck.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.Someone become aware of the issue when the device came apart as the nurse was priming.No medication was being used with the product.There was no leakage.Although there was a delay in therapy, there was no human harm.This captures the second 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 device is not available for investigation.Without the return of the device, a probable cause is unable to be determined.

• 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: 14713749
• MDR Text Key: 302857545
• Report Number: 9617594-2022-00176
• 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?: Device Not Returned to Manufacturer
• 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.