MAUDE Adverse Event Report: ICU MEDICAL, INC. TRANSPAC; CATHETER, CONTINUOUS FLUSH

Model Number 42587-05

Device Problems Backflow (1064); Break (1069); Detachment of Device or Device Component (2907)

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

Event Date 03/06/2020

Event Type  malfunction  

Event Description

Transpac it monitoring kit lot # 4140090 has been used on several different icu patients this weekend.The blue "fast flush" device has broken off 2x, the plunger located on the pull back mechanism broke off; a back flow of blood was noted through the pull back, out the hole on top of it and puddle onto the patient's floor.Another set would not prime.

• Brand Name: TRANSPAC
• Type of Device: CATHETER, CONTINUOUS FLUSH
• Manufacturer (Section D): ICU MEDICAL, INC.; 4455 atherton dr; salt lake city UT 84123
• MDR Report Key: 10038449
• MDR Text Key: 190337514
• Report Number: 10038449
• 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: 04/02/2020,03/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 42587-05
• Device Lot Number: 4040090
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/02/2020
• Event Location: Hospital
• Date Report to Manufacturer: 05/08/2020
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1