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

Lot Number 3166355

Device Problem Component Missing (2306)

Patient Problem No Information (3190)

Event Date 09/19/2016

Event Type  malfunction  

Event Description

Item opened onto a sterile field for use.It was noted that the wrong product tubing was in package.The transducer set inside this packaging is incorrect.

• Brand Name: TRANSPAC IV
• Type of Device: TRANSDUCER, BLOOD-PRESSURE, EXTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL INC.; 4455 atherton dr.; salt lake city UT 84123
• MDR Report Key: 6092506
• MDR Text Key: 59590251
• Report Number: 6092506
• 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: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Lot Number: 3166355
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/26/2016
• Device Age: 1 DY
• Event Location: Hospital
• Date Report to Manufacturer: 09/26/2016
• 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