MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSDUCER, 84 INCH (213 CM), 3 ML/HR, MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 011-0P232-01

Device Problem Separation Problem (4043)

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

Event Date 08/01/2023

Event Type  malfunction  

Event Description

The event occurred on an unknown date involving a transducer, 84 inch (213 cm), 3 ml/hr, macrodrip where the customer reported that the equipment has a vulnerability at the junction point with sodium chloride (nacl) tubing.Their intensive care unit has alerted them to a recurring issue with the pressure sets, reference: (b)(4).It is not known if the event occurred with patient involvement.It is also not known if the event resulted in a patient harm.No additional information was provided.

Manufacturer Narrative

The device is not available for investigation.However, a picture was provided for evaluation.The investigation is still pending.

Manufacturer Narrative

No sample or videos were returned for evaluation.However, images was provided by the customer showing the involved device.A failure mode was not able to be identified from the image provided.The reported complaint could not be confirmed from the information provided.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.

• Brand Name: TRANSDUCER, 84 INCH (213 CM), 3 ML/HR, MACRODRIP
• 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: 17723353
• MDR Text Key: 323289098
• Report Number: 9617594-2023-00682
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00840619035464
• UDI-Public: (01)00840619035464(17)260201(10)13547024
• 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: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 011-0P232-01
• Device Lot Number: 13547024
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/25/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/15/2023
• 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: SODIUM CHLORIDE (NACL), MFR UNK.; UNSPECIFIED TUBING, MFR UNK.