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

Model Number 7300

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem No Information (3190)

Event Date 12/04/2020

Event Type  malfunction  

Event Description

It was reported that a smiths medical pump alarmed.No issue observed during the preparation, the pump alarmed, no cassette.The nurse wanted to take the pump and disconnected the tubing from the flexible part during its handling.Moad.

Manufacturer Narrative

Other, other text: one unit was received for evaluation.The unit was filled using a syringe then was connected to the pump cadd legacy plus [id 1.0238; due date: july, 2021]; the units were primed and connected without difficult, the pump was set running and any alarm was activated.The failure was not confirmed.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: 11283943
• MDR Text Key: 230453211
• Report Number: 3012307300-2021-00899
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586027215
• UDI-Public: 10610586027215
• Combination Product (y/n): N
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Type of Report: Initial,Followup
• Report Date: 04/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 04/06/2020
• Device Model Number: 7300
• Device Catalogue Number: 21-7301-24
• Device Lot Number: 3955178
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 70 YR