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

Model Number 21-7052-24

Device Problem Connection Problem (2900)

Patient Problems Diarrhea (1811); Headache (1880)

Event Date 02/01/2021

Event Type  malfunction  

Event Description

Information was received indicating that the cadd extension set became disconnected from the cassette end. It was reported that the patient went without medications for several hours due to the malfunction. The patient's diagnosis is pulmonary arterial hypertension. The patient felt unwell. Then had to endure side effects of sudden start of medication when reconnected (headache, flushing, diarrhea) which lasted in one of the cases for a couple of days. It was a significant contributor to patient anxiety. To continue therapy, the patient reattached and remade her medication as needed and symptoms resolved.

• 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: david halverson ; 6000 nathan lane north; glossop road; minneapolis, MN 55442
• MDR Report Key: 11408734
• Report Number: 3012307300-2021-01732
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586020346
• UDI-Public: 10610586020346
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K974013
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: 21-7052-24
• Device Lot Number: 4025966
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/01/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: No Information
• Date Manufacturer Received: 05/09/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/19/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Weight: 0