MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 7302

Device Problems False Alarm (1013); Improper Alarm (2951)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

Manufacture and expiration date unavailable with information provided.

Event Description

Information was received that an infusion pump alarmed "no disposable, clamp tubing" while in use with a smiths medical reservoir cassette.No patient injury resulted.

• Brand Name: CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION
• 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. MPAU; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7664824
• MDR Text Key: 113282542
• Report Number: 3012307300-2018-02597
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027239
• UDI-Public: 10610586027239
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 7302
• Device Catalogue Number: 21-7302-24
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/11/2018
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1