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

Model Number	42646-06
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac® iv monitoring kit with safeset¿ reservoir and 2 blood sampling ports, 84" tubing, disposable transducer, 3 ml squeeze flush, macrodrip (pole mount).It was reported that the tubing has been disconnected from the source and it was detected by the nurse right away.The tubing was hooked up to a central line for central venus pressure monitoring and came apart.The tubing was properly secured with a line holder about 10 minuets prior, the pressure tubing was used for a blood draw from central venus line without any issue.Lab came back and needed additional blood and the patient was not repositioned and the tubing was not touched since the past draw and needed additional blood and the patient was also not reposistioned.When the vamp was lifted off the bed, a portion of the tubing came apart with very little force.A small portion of the pressure tubing was left attached to the cvl and the tubing was immediatley clamped proximal to the patient.The tubing was unhooked from the cvl.The tubing was not ripped and the end dud not have a luer lock or any attachment where it could be intentionally disconnected.The tubing seemed abnormally weak there was patient involvement and no patient harm reported.
Additional Manufacturer Narrative
The device is available to be returned for evaluation; however, it has not yet been received.Medwatch report mw5119088.
Additional Manufacturer Narrative
The complaint of separation on the 426460406 could not be confirmed by investigation.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The device history review for lot 12161624 was reviewed and no non conformities were found that would have led to the reported complaint.

• Brand Name: TRANSPAC® IV MONITORING KIT WITH SAFESET¿ RESERVOIR AND 2 BLOOD SAMPLING PORTS,
• 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: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 17318330
• Report Number: 9617594-2023-00380
• Device Sequence Number: 17671204
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)251101(10)12161624
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/28/2023

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 Expiration Date: 11/01/2025
• Device Model Number: 42646-06
• Device Catalogue Number: 426460406
• Device Lot Number: 12161624
• 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: 06/28/2023
• Supplement Date Received by Manufacturer: 09/11/2023
• Initial Report FDA Received Date: 07/13/2023
• Supplement Report FDA Received Date: 10/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/01/2023
• 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
• Concomitant Medical Products and Therapy/Usage Dates: CENTRAL VENOUS LINE, MFR UNK; CENTRAL VENUS PRESSURE MONITORING, MFR UNK
• Patient Sex: Unknown