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

Catalog Number 21-7302-24

Device Problem Disconnection (1171)

Patient Problem Nausea (1970)

Event Date 05/17/2018

Event Type  malfunction  

Manufacturer Narrative

Please see mfr # 3012307300-2018-02250 for related device incident.(b)(6).

Event Description

Patient reported that his ambulatory infusion pump, which had previously undergone a sensor adjustment, stopped infusing and emitted a "no disposable" alarm while the patient was at school.Given that the patient was at school and did not have a back-up pump he contacted the hospital who instructed him to flatten a part of the cassette tube which came in contact with the pump's sensor as an emergency measure.This intervention was successful and the alarm stopped.The pump was suspended for approximately 1 hour and it made him feel a little sick.

• Brand Name: CADD® CADD¿ MEDICATION 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.; 1265 grey fox road; st. paul MN 55112
• Manufacturer Contact: dave halverson ; 6000 nathan lane north; minneapolis, MN 55442 ; 7633833310
• MDR Report Key: 7584152
• MDR Text Key: 110576380
• Report Number: 3012307300-2018-02106
• 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: consumer,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/08/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 21-7302-24
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 16 YR