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

Device Problem Inaccurate Delivery (2339)

Patient Problems Headache (1880); Nausea (1970); Pulmonary Hypertension (4460)

Event Date 04/01/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported while using the disposable extension set the patient experiencing severe symptoms with the disposable exchanges.Patient experienced nausea and headache around disposable exchange time.They have their remodulin doses titrated down and weaned off pressors.To resolve symptoms, required treatment included added pressors, moved to icu, profound hypertension (symptoms are not uncommon, but are not this severe.

Manufacturer Narrative

No product was returned.We are unable to confirm the reported complaint.If the product is returned, smiths medical will reopen this complaint for further investigation.No serial/lot number was provided; therefore, a device history record (dhr) review could not be conducted.

Manufacturer Narrative

Lot and item number have not been provided to date, d4 model number, lot number, udi number, expiration date and h4 are unavailable, corrected data: d1, d3, g2.Correction to follow-up 001, h2: device evaluation.

• 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): NULL
• Manufacturer Contact: jim vegel
• MDR Report Key: 16776904
• MDR Text Key: 313747838
• Report Number: 3012307300-2023-04332
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• 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,Followup,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/16/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1