MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD MEDICATION RESERVOIR; SET, IV FLUID TRANSFER

Catalog Number 21-7302-24

Device Problems Air Leak (1008); Partial Blockage (1065); Filling Problem (1233)

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

Event Date 06/18/2018

Event Type  malfunction  

Event Description

Pt complaining that she cannot fill her cassette with machine or remove air bubbles due to the spring clamp blocking the tubing.Advised pt that the previous cassettes that were sent are discontinued, are being replaced with the cassettes with the green spring clamp.Advised pt pharmacy will have cnss reach out to visit her.No other info known.Mfr: united therapeutics.Dates of use: from (b)(6) 2018.Diagnosis or reason for use: pah.

• Brand Name: CADD MEDICATION RESERVOIR
• Type of Device: SET, IV FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 7637941
• MDR Text Key: 112454542
• Report Number: MW5078067
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 06/18/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3607927
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/25/2018
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 70 YR