MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. De R.L. De C.V. Transpac® IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush Devi; transducer, blood-pressure, extravascular

Catalog Number	46115-68
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/22/2026
Type of Reportable Event	Malfunction
Event or Problem Description
The event involved a transpac iv monitoring kit 84 inches disposable transducer, 3 ml squeeze flush device, macro drip un-bonded reported that the cvp waveform was not displaying appropriately on the monitor.The rn troubleshot the cvp line and identified a crack in the tubing at the connection to the stopcock.Normal saline was noted to be leaking onto the bed for an unknown duration before the issue was recognized.Following identification of the leak, all cvp tubing was replaced.There was no patient involvement.
Additional Manufacturer Narrative
The device is available for evaluation; however, has not been received.

• Brand Name: Transpac® IV Monitoring Kit, 84", Disposable Transducer, 3 ml Squeeze Flush Devi
• 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. NA 22790 ; MX 22790
• Manufacturer Contact: reed covert ; 951 calle amanecer; san clemente, CA 92673 ; +1(224)706-2300
• MDR Report Key: 50777260
• Report Number: 9617594-2026-01267
• Device Sequence Number: 9792119
• Product Code: DRS
• UDI-Device Identifier: 00887709087040
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2026

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: 46115-68
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/11/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/26/2026
• Initial Report FDA Received Date: 09/15/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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