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

Model Number 21-7324-01

Device Problem Failure to Infuse (2340)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

It was reported the device did not infuse and the clinician had to reset the cassette and then the infusion started.No alarm sounded to state that infusion was not running.No patient injury was reported.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: we experienced a pump recording delivery of medications yet not actually delivering the medications.When we changed the set, worked again.We suspect that there may be an issue with the sets.The pump serial number is (b)(4).The set lot numbers on site are lot 4248632 and lot 4232350.Additional information received via email from customer on (b)(6) 2022 and attached by icu medical in complaint: we have another set (lot 4232350) that seems to have a similar issue.When priming, the pump sounds like it is active but no fluid is coming out and it is recording the volume.The set was replaced on the same pump and it worked properly.Additional information received via email from customer (chief, department of anesthesiology and critical care) on (b)(6) 2022 and attached by icu medical in complaint; i am assuming it is an issue with the tubing sets themselves and i would assume we are not alone with this issue.No patient injury was reported.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14567638
• MDR Text Key: 293360819
• Report Number: 3012307300-2022-10346
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Device Lot Number: 4232350
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/05/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1