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

Catalog Number 21-7322-24

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/02/2018

Event Type  malfunction  

Manufacturer Narrative

Report source: (b)(6).

Event Description

Information was received that the cadd administration set for a cadd solis pump had a "no disposable, clamp tubing" alarm.No reported adverse effects.

Manufacturer Narrative

Device evaluation- one used sample was returned for evaluation.During examination, the pump tube on top of the cassette housing showed a deformation (compressed area).The returned device was given functional testing: the device was attached to an infusion pump and the infusion pump gave the alarm "cassette not attached properly".This root cause could not be definitely estalished.However, the issue was determined likely to have occurred due to either the compression damage seen on the pump tube or the cassette housing not meeting dimensional specifications.The manufacturing facility performed a review of the manufacturing process.The review showed that assembly process was being performed as per procedures.The manufacturing facility also performed an in-process visual inspection of 32 products that were in the assembly area: this inspection showed no issues with the products being assembled.The manufacturing facility has previously taken corrective actions to address both potential root causes.To address the potential for pump tube damage not being identified during inspection, the manufacturing supervisor notified the inspection operators of the issue.To address the potential for cassette housing not meeting dimensional specifications the manufacturing facility has: updated the specifications for the pressure plates, updated the molding tool for this component and implemented a dimensional inspection as part of the incoming inspection for this component.

• Brand Name: CADD ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 8030195
• MDR Text Key: 125912573
• Report Number: 3012307300-2018-08077
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029646
• UDI-Public: 10610586029646
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 21-7322-24
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/10/2018
• Initial Date Manufacturer Received: 10/02/2018
• Initial Date FDA Received: 11/01/2018
• Supplement Dates Manufacturer Received: 12/19/2018
• Supplement Dates FDA Received: 01/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1