MAUDE Adverse Event Report: ST PAUL CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7391-24

Device Problems Device Difficult to Setup or Prepare (1487); Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954)

Patient Problems Pain (1994); No Information (3190)

Event Date 09/22/2020

Event Type  malfunction  

Event Description

Information was received that during use of this smiths medical cadd administration sets, under deliver of medication to patient was noticed.It was reported that the customer had issues with under delivery and air inline when priming sets.No reported adverse effects.

Event Description

Additional information was received indicating that the fact that the patient received less than the prescribed dose of opioid on their first night post operation did result in him having high severe pain.The pump was programmed to deliver a 0.5ml pca dose with a 5 minute lockout and no continuous rate.It was in progress for approximately 19 hours.The pump stated 77.7mls of the 100ml bag had been infused, however, 73mls remained in the bag.It was also reported that it took 22mls of fluid to prime the pca administration set (as opposed to the 3-4mls which is the usual amount it takes).Since this incident, the facility has had several lines that have taken up to 10mls to prime as they seem to fill with air.

Manufacturer Narrative

Other, other text: returned device was received in good physical condition.During the evaluation of the device the customer reported condition was confirmed.Problem source was traced to manufacturing.The device history record was reviewed and showed that this device met all manufacturing specification for product released for distribution.No issues were identified that would have impacted this event.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• MDR Report Key: 10672704
• MDR Text Key: 211124951
• Report Number: 3012307300-2020-10327
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027512
• UDI-Public: 10610586027512
• 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,Followup
• Report Date: 01/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 21-7391-24
• Device Catalogue Number: 21-7391-24
• Device Lot Number: 3844235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1