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	02/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is not available for evaluation.Without the returned device a probable cause is unable to be determined.
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 stated that the a-line separated in half during a procedure.There was patient involvement, however no human harm and no delay in therapy.
Additional Manufacturer Narrative
No product samples, videos, or photographs were returned for investigation.The lot history was reviewed and there were no nonconformities found that would have contributed to the reported complaint.A probable cause cannot be identified based on the information that has been provided.The reported complaint cannot be confirmed.

• 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: 13980787
• Report Number: 9617594-2022-00070
• Device Sequence Number: 5994667
• Product Code: DRS
• UDI-Device Identifier: 00840619028053
• UDI-Public: (01)00840619028053(17)240701(10)5487184
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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): 03/11/2022

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: 07/01/2024
• Device Model Number: 42646-06
• Device Catalogue Number: 426460406
• Device Lot Number: 5487184
• 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: 03/11/2022
• Supplement Date Received by Manufacturer: 04/20/2022
• Initial Report FDA Received Date: 04/01/2022
• Supplement Report FDA Received Date: 04/21/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/01/2021
• 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