MAUDE Adverse Event Report: PARI RESPIRATORY EQUIPMENT, INC. TUBING/WING TIP; TUBING, PRESSURE AND ACCESSORIES

Device Problem Leak/Splash (1354)

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

Event Date 11/26/2018

Event Type  malfunction  

Event Description

Spontaneous call from patient, spoke with patient regarding tubing leak.Patient noticed leak last night but it is very minor; leak is near where tubing and iv line connect.Couriered shipment.Patient had 53 ml left in cassette.No side effects reported.Dose or amount: 30 ng/kg/min; frequency: continuous; route: iv.Dates of use: from (b)(6) 2018 to current; diagnosis or reason for use: pah.Strength: 1.5mg.

• Brand Name: TUBING/WING TIP
• Type of Device: TUBING, PRESSURE AND ACCESSORIES
• Manufacturer (Section D): PARI RESPIRATORY EQUIPMENT, INC.
• MDR Report Key: 8155103
• MDR Text Key: 130318186
• Report Number: MW5082049
• Device Sequence Number: 1
• Product Code: BYX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 43 YR