MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 42800-27

Device Problem Disconnection (1171)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 01/17/2024

Event Type  Death  

Event Description

The event involved transpac¿ it monitoring kit, 60" safeset reservoir, 2 blood sampling port, 3ml flush device, macrodrip where a disconnection of tubing at blood sampling port was reported.The product was not discolored during the entire use.The event occurred during infusion and there was patient harm due to bleeding that occurred when the device malfunctioned and broke apart.The patient needed to be turned and repositioned for clean-up.Patient sustained respiratory arrest while staff was attempting to clean the patient up.Patient then expired one day after initial arrest and product issue, and after being made comfort care.

Manufacturer Narrative

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

Manufacturer Narrative

The reported complaint of separation was confirmed based on the image provided by the customer.No product samples, videos were returned for investigation.However an image was provided by the customer showing the area of the defect.A failure mode was not able to be identified from the image provided by the customer.Therefore, a comprehensive failure investigation cannot be performed and a cause cannot be determined.Without the return of the reported sample, a probable cause could not be confirmed.The device history report (dhr) for lot 13618180 was reviewed and no non conformities were found that would led to the reported complaint.

• Brand Name: TRANSPAC¿ IT MONITORING KIT, 60" SAFESET RESERVOIR, 2 BLOOD SAMPLING PORT, 3ML F
• 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: 18727280
• MDR Text Key: 335623444
• Report Number: 9617594-2024-00161
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K052828
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/16/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 42800-27
• Device Lot Number: 13618180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• 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
• Patient Outcome(s): Death