MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC; IV PRESSURE MONITORING KIT

Catalog Number 42648-06

Device Problem Failure to Prime (1492)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/14/2018

Event Type  malfunction  

Event Description

Nurse went to prime aline tubing and roller clamp was clamped and left tubing stuck together and was unable to prime with saline.Per site reporter manufacturer sent me a shipping label tracking number.

• Brand Name: TRANSPAC
• Type of Device: IV PRESSURE MONITORING KIT
• Manufacturer (Section D): ICU MEDICAL, INC.; 951 calle amanecer; san clemente CA 92673
• MDR Report Key: 7816140
• MDR Text Key: 118244841
• Report Number: 7816140
• Device Sequence Number: 1
• Product Code: DRS
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/27/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 42648-06
• Device Lot Number: 3710699
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2018
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/22/2018
• Event Location: Hospital
• Date Report to Manufacturer: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1