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
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	01/17/2024
Type of Reportable Event	Death
Event or Problem 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.
Additional Manufacturer Narrative
The device is not available for evaluation.However, a photo was provided.The investigation is pending.
Additional 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
• Common Device Name: 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
• Report Number: 9617594-2024-00161
• Device Sequence Number: 17729990
• Product Code: DRS
• UDI-Device Identifier: 00887709097995
• UDI-Public: (01)00887709097995(17)260401(10)13618180
• Combination Product (Y/N): N
• Initial Reporter State: VT
• Initial Reporter Country: US
• PMA/510(K) Number: K052828
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/21/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/01/2026
• Device Catalogue Number: 42800-27
• Device Lot Number: 13618180
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/17/2024
• Supplement Date Received by Manufacturer: 02/20/2024
• Initial Report FDA Received Date: 02/16/2024
• Supplement Report FDA Received Date: 03/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown