MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNSPECIFIED TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number UNKNOWN

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

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

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

Although the device was requested to be returned for evaluation, it has not been received.Without the returned device, a probable cause is unable to be determined.

Event Description

It was reported that a transducer disconnected and generated a leak during patient use.The reporter stated, "transducer disconnect at side port.Patient experienced loss of blood".The product was contaminated or contained a biohazard or chemotherapeutic agent.Someone became aware of the issue when staff noticed blood and port disconnection.No medication was being used with this product.There was no patient harm reported.

Manufacturer Narrative

The reported complaint of separation was confirmed on the returned set.During visual inspection of the sample, the pvc tubing was found separated from the transpac luer pocket.When the end of the tubing was microscopically examined, insufficient adhesive coverage was observed.The probable cause of the insufficient adhesive coverage on the tubing had occurred due to an error during assembly at ensenada.A device history review (dhr) lot # review could not be conducted because no lot number(s) was identified.

• Brand Name: UNSPECIFIED TRANSDUCER
• 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: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 18342265
• MDR Text Key: 330668293
• Report Number: 9617594-2023-01169
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• 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,Followup
• Report Date: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/16/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/26/2023
• 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