MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	426500406
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/26/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone has an extension # (b)(6).The device was received for evaluation.The investigation is pending.
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 it was reported that the tube disconnected on a patient.There was patient involvement, no patient harm and no delay in therapy.
Additional Manufacturer Narrative
The reported complaint of separation was confirmed on the returned set.An image was provided by the customer showing the area of the defect.During visual inspection, the safeset port was received separated from the 25" pressure tubing.When the end of the tubing was microscopically examined, insufficient solvent coverage was observed.The probable cause of the pressure tubing separation had occurred due to insufficient solvent coverage on the tubing during assembly at manufacturing.A device history report (dhr) lot # review could not be conducted because no lot number(s) was/were identified.

• Brand Name: TRANSPAC¿ TRIFURCATED MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLIN
• 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: 20302486
• Report Number: 9617594-2024-01335
• Device Sequence Number: 18314407
• Product Code: DRS
• UDI-Device Identifier: 00840619045029
• UDI-Public: (01)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: Non-Healthcare Professional
• 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: 426500406
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2024
• Supplement Date Received by Manufacturer: 10/17/2024
• Initial Report FDA Received Date: 09/25/2024
• Supplement Report FDA Received Date: 11/14/2024
• 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