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

Catalog Number 21-7001-24

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/03/2019

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical cadd cassette reservoirs, the pump displayed "no message" error alarm.It was reported that when the customer detached the cassette from the pump and attached again, the alarm stopped.No patient injury.No reported adverse effects.

• Brand Name: CADD CASSETTE RESERVOIR
• 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: 8321375
• MDR Text Key: 135555616
• Report Number: 3012307300-2019-00475
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586022111
• UDI-Public: 10610586022111
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K843772
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7001-24
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/11/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 6 YR