MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD CASSETTE RESERVOIRS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 21-7302-24

Device Problem Infusion or Flow Problem (2964)

Patient Problem No Code Available (3191)

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical cadd cassette reservoirs, under delivery was noted.Reported that the neck on the bladder of the cassette reservoirs gets pinched off when administering medication through the pump which result in the patient feeling very ill because the medication fluid was not been delivery at the correct rate.It was also reported that the bladders in the cassettes were "bent" on all sides, and when liquid was placed in them, they form an "s" shape, which affects the flow of the liquid through the pump.Subsequently, the patient switched to a different cassette reservoirs but had similar results.No additional adverse effects reported.

• Brand Name: CADD CASSETTE RESERVOIRS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 8259551
• MDR Text Key: 133511951
• Report Number: 3012307300-2019-00316
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 07/05/2023
• Device Catalogue Number: 21-7302-24
• Device Lot Number: 3630804
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/21/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/16/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1