MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLE P; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42801-30
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/02/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned for evaluation; however, testing has not yet been completed.
Event or Problem Description
It was reported that a transpac¿ it trifurcated monitoring kit, 84" safeset reservoir, 2 blood sample ports, 3ml flush devices, un-bonded macrodrip (pole mount) was found to have a broken connector leading to a leak during patient use.The reporter stated that patients bleeding out arterial lines.The event date started on 24-may-2024 up until 02-oct-2024.No conversion from another supplier, the same product has been used for a long time.The risk concern is the patient safety concern.A sample photo was provided showing products affected inside a clear plastic container.There was no patient harm reported.
Additional Manufacturer Narrative
The reported complaint of broken connector was confirmed.Two images were provided by the customer, one showing a break at the stopcock and the other one showing a pressure tubing separation from the safeset port.The safe set port is not part of the returned set.During visual inspection of the sample, the three-way stopcock was observed to be broken.Beach marks were observed at the broken region.The probable cause of the breakage had occurred due to unintentional bending and twisting forces applied during use.Without the return of the pressure tubing and safeset port, a probable cause could not be identified.A device history lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC¿ IT TRIFURCATED MONITORING KIT, 84" SAFESET RESERVOIR, 2 BLOOD SAMPLE P
• 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; colonia rancho santa clara, ma; ensenada, b.cfa. ; MX
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20588177
• Report Number: 9617594-2024-01552
• Device Sequence Number: 12958754
• Product Code: DRS
• UDI-Device Identifier: 00887709120792
• UDI-Public: 00887709120792
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 12/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 42801-30
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2024
• Supplement Date Received by Manufacturer: 11/12/2024
• Initial Report FDA Received Date: 11/01/2024
• Supplement Report FDA Received Date: 12/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown