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

Model Number 21-7324-01

Device Problem Insufficient Flow or Under Infusion (2182)

Patient Problems No Consequences Or Impact To Patient (2199); No Information (3190)

Event Date 11/20/2019

Event Type  malfunction  

Event Description

Information was received indicating that at the end of therapy, under infusion was noted on a smiths medical cadd administration set.The reporter indicated that a volume discrepancy of 30-40%, or 30-40ml was noted on a 100ml reservoir while the pump indicated that the reservoir was low or depleted.The reporter also indicated that per customer's email, and event log for the most recent event, customer stated 30-10ml was still left in the reservoir, but the pump reported that 87.35ml used (out of 100ml).Subsequently, the reporter indicated the pump was tested with a standard administration set and found to have excellent accuracy.No adverse effects were reported.

Event Description

Information was received that the incident did occur while in patient use, and that no patient injury resulted. pump was used for labor analgesia, with continuous infusion of pcea and/or pi.The customer tested a pump and observed that it was more accurate delivering a continuous infusion, but noticed inaccuracies with bolus infusions.

• Brand Name: CADD ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 9531337
• MDR Text Key: 177394974
• Report Number: 3012307300-2019-07333
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

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 Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 3863381
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/02/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 01/31/2020
• Supplement Dates FDA Received: 02/05/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1