• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

SMITHS MEDICAL ASD, INC. CADD® CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 21-7302-24
Device Problems Device Displays Incorrect Message (2591); Device Operates Differently Than Expected (2913)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/04/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6).
 
Event Description
Information was received indicating that this cassette caused alarms to occur when used with multiple ambulatory infusion pumps. Troubleshooting ruled out the pumps and was unable to resolve the cassette issue. No adverse patient effects were reported.
 
Manufacturer Narrative
One cadd® cadd® medication cassette reservoir was returned in used condition. The customer's reported problem was "a no disposable, pump won't run alarm went off". The cassette was visually inspected for damage at a distance of 12" to 24" and normal conditions of illumination. No damage was detected. The sample was connected and tested on a pump. The height of the arch of the pump tube was within specification and no alarms were activated during the testing. The manufacturing and quality inspection processes were reviewed and considered adequate and correct. The failure mode could not be duplicated. The root cause of the reported problem is unknown.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameCADD® CADD® MEDICATION CASSETTE RESERVOIRS WITH FLOW STOP FREE-FLOW PROTECTION
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
SMITHS MEDICAL ASD, INC.
6000 nathan lane north
minneapolis MN 55442
Manufacturer (Section G)
SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V.
a d no.4
parque industrial internaciona
tijuana, bc
MX
Manufacturer Contact
dave halverson
6000 nathan lane north
minneapolis, MN 55442
7633833310
MDR Report Key7397004
MDR Text Key104422509
Report Number3012307300-2018-00655
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K040636
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/04/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number21-7302-24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2018
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received05/21/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/30/2017
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-