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

Device Problem Fluid/Blood Leak (1250)

Patient Problems Nausea (1970); Vomiting (2144); Hot Flashes/Flushes (2153)

Event Date 10/10/2023

Event Type  malfunction  

Event Description

It was reported that during use of a device system delivering remodulin, the tubing was found to be leaking.The patient experienced nausea, vomiting, and flushing.Due to this, the dose was reduced from 0.052ml/hour to 0.024ml/hour.Per the healthcare provider, the patient was to stay at this dose and then titrate back to goal dose once the side effects subside.

Manufacturer Narrative

Other text: d4: catalog, lot, expiration date, udi number unavailable.G5: 510k number unavailable.H4: device manufacture date unavailable.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional information becomes available.

Manufacturer Narrative

Other, other text: additional information is provided for h.2 and h.6.No product was returned.If the product is returned this complaint will be reopened for further investigation.No lot number was provided; therefore, a history record review could not be conducted.For all enquiries or follow-up questions related to the record, do not use regulatory.Responses@smiths-medical.Com located in sections g.1., please direct those to the following: regulatory.Responses@icumed.Com.

• Brand Name: CADD CLEO INFUSION SET
• 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: 18175867
• MDR Text Key: 328580868
• Report Number: 3012307300-2023-10651
• 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: Other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/08/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/20/2023
• 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?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/01/2024
• 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
• Patient Age: 28 YR