MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC IT INTEGRATED PRESSURE TRANSDUCER; TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR

Catalog Number 42648-06

Device Problems Cut In Material (2454); Connection Problem (2900)

Patient Problem No Information (3190)

Event Date 02/10/2016

Event Type  Injury  

Event Description

After removing the device from the package it was observed that the device had a cut in the line.There was another incident with the same type of device: the other device that was found to be defective was connected to a patient, when it was noticed that the line wasn't connected as it should be.A replacement had to be retrieved immediately as the arterial line was already in place and the new safeset had to be primed and ready to go.

• Brand Name: TRANSPAC IT INTEGRATED PRESSURE TRANSDUCER
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 5488791
• MDR Text Key: 39976876
• Report Number: 5488791
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 10/01/2018
• Device Catalogue Number: 42648-06
• Device Lot Number: 3131060
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/26/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 02/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1