MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SEE SECTION H11; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	42650
Medical Device Problem Codes	Leak/Splash (1354); Material Separation (1562)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	08/31/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac¿ trifurcated monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84", 3 3 ml squeeze flushes, 3 disposable transducers, macrodrip (pole mount) where the customer reported that the tubing snapped while taking a patient to ct.The customer said this seemed to be happening more often.The customer stated that there was a small amount of blood loss and then a large clot was found in the tubing; the nurse checked line/pulled back prior to flushing and was able to withdraw the clot.There was about a 20 minute delay in therapy due to not obtaining/able to read continuous blood pressure throughout scan; the nurse used cuff pressures instead.There was patient involvement; but no adverse outcome occurred as a consequence of this event.
Additional Manufacturer Narrative
Section d1.Transpac¿ trifurcated monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84", 3 3 ml squeeze flushes, 3 disposable transducers, macrodrip (pole mount) the device has been received for evaluation, however, investigation is not yet complete.
Additional Manufacturer Narrative
The reported complaint of breakage was confirmed on the returned set.During visual inspection of the sample, one of the transpac is received broken.A part of the male luer of the transpac is still inside female luer of the three way stopcock.It is how the transpac was broken.The probable cause of the breakage is unknown.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: SEE SECTION H11
• 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. 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 20351429
• Report Number: 9617594-2024-01368
• Device Sequence Number: 8201514
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: 00840619045029
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K061573
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2024

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: 42650
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/05/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/03/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 11/12/2024
• 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