MAUDE Adverse Event Report: ST PAUL CADD; PUMP, INFUSION

Model Number 21-7324-01

Device Problem Infusion or Flow Problem (2964)

Patient Problem Pain (1994)

Event Date 06/24/2021

Event Type  malfunction  

Manufacturer Narrative

The lot number is unknown at this time.

Event Description

Information was received indicating that at the end of therapy with a smiths medical cadd administration set, it was noted that it did not deliver any medication.It was also reported that the patient experienced pain despite pressing the button of remote three times.No further adverse effects were reported.

Manufacturer Narrative

Other text: this mdr was generated under protocol (b)(4), as a result of warning letter cms# (b)(4).No product sample was received; therefore, visual and functional testing could not be performed.The reported issue could not be confirmed as no product sample was received for evaluation.If the product is returned, the manufacturer will reopen this complaint for further investigation.D4: catalog number is unknown.D4: udi information is unknown.G5: premarket (510k) number is unknown.E4: initial reporter also sent report to fda is unknown.Update h6 and h10.

• Brand Name: CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): NULL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: david halverson ; 6000 nathan lane north; parc euromedecine; minneapolis, MN 55442
• MDR Report Key: 12274257
• MDR Text Key: 264962409
• Report Number: 3012307300-2021-08037
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586029653
• UDI-Public: 10610586029653
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K040636
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/04/2023

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: Lay User/Patient
• Device Model Number: 21-7324-01
• Device Catalogue Number: 21-7324-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 07/05/2021
• Initial Date FDA Received: 08/04/2021
• Supplement Dates Manufacturer Received: 04/27/2023
• Supplement Dates FDA Received: 05/04/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Female