MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SINGLE TRANSPAC® IT MONITORING KIT W/ 104" RED STRIPE TUBING; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0J729-01

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

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

Event Date 05/12/2023

Event Type  malfunction  

Event Description

The event involved a single transpac® it monitoring kit w/ 104" red stripe tubing where it was reported that during patient use, the pressure head of the arterial catheter broke from its holder, so there was no longer any arterial catheter in full noradrenaline relay.This required a quick change of tubing.There was no significant delay in therapy.The blood loss was not significant.The medical intervention was the tubing was quickly changed.There was no physical defect noted prior use.There was patient involvement but no adverse event or human harm.

Manufacturer Narrative

The device is available for evaluation- it has not been received.

Manufacturer Narrative

D9 - date returned to mfg on 10/5/2023.Received one used.List #011-0j729-01, single transpac® it monitoring kit w/ 104" red stripe tubing; lot #unknown.--> one (1) used.List #unknown, baxter viaflo chlorure do sodium 0,9% 1000 ml intravenous bag; lot #22k01e9s.Received sample photos.The reported complaint of transpac broken was confirmed.Two images were provided by the customer showing the involved device.During visual inspection, the blue housing around the transducer was found separated, exposing the wires of the transpac and the white wire was found separated from the transducer.The blue housing was not returned for evaluation.No plastic deformations or visual anomalies were observed on the returned sample.Representative samples were fixed to a mount and the tensile strength was measured using the instron.The separation was able to be recreated by connecting the transpac to a mounting bracket and then pulling the white cable at a 90deg angle away from the transpac.Seven (7) out of 30 tested samples pulled apart, exposing the wires of the transpac.However, after conducting an engineering study on this as a potential failure mode, it was determined that this was not the likely cause of the separation as this pulling force on the cable was more likely to lead to the transpac pulling out of the mount and not the reported complaint of the blue housing separating.A probable cause of the separation cannot be determined at this time.

• Brand Name: SINGLE TRANSPAC® IT MONITORING KIT W/ 104" RED STRIPE TUBING
• 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: 16989772
• MDR Text Key: 316251621
• Report Number: 9617594-2023-00200
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: FR
• 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: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-0J729-01
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2023
• 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: NORADRENALINE, MFR UNK.