MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number	46106-91
Medical Device Problem Code	No Flow (2991)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/08/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation but investigation is not yet complete.
Event or Problem Description
The event involved atranspac® iv monitoring kit w/03 ml squeeze flush and macrodrip where the customer reported that their nicu has been experiencing issues with arterial line occlusion alarms on their bd alaris pumps when using the transpac kit.The infusion rate is typically set at 1 ml/hr.The customer stated that their troubleshooting has been unsuccessful the majority of the time and they've only been successful correcting the issue when the caps are changed on the transpac.The majority of the time it is not successful, and they have to change out the set.The incident occurred during patient use; no medication was being used with the device.Harm was not reported as a consequence of this event.
Additional Manufacturer Narrative
The reported complaint of increasing pressure alarms was not confirmed.No visual anomalies were observed.When the transpac was electrically tested, and a wave form was able to be zeroed with the waveform visible on the monitor.When the sample was tested for a continuous flow rate when the squeeze flush is in an inactivated state, the sample passed the continuous flow rate.The product had performed per the specifications.

• Brand Name: TRANSPAC® IV MONITORING KIT W/03 ML SQUEEZE FLUSH AND MACRODRIP
• 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: 21980302
• Report Number: 9617594-2025-00931
• Device Sequence Number: 12957100
• Product Code: DRS
• UDI-Device Identifier: 00887709050914
• UDI-Public: 00887709050914
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/30/2025

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: 46106-91
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/21/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/08/2025
• Supplement Date Received by Manufacturer: 06/05/2025
• Initial Report FDA Received Date: 05/07/2025
• Supplement Report FDA Received Date: 06/30/2025
• 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