MAUDE Adverse Event Report: NULL CADD EXTENSION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Fluid/Blood Leak (1250)

Patient Problem Dizziness (2194)

Event Date 11/01/2022

Event Type  malfunction  

Event Description

It was reported that per mw5113539: patient states that she had covid approximately 3 weeks ago and was not well enough to increase regularly at that time.Also around that time, patient states that she didn't realize her pump was off, was off of her remodulin for about 9 hours, and was dizzy and not feeling well upon restarting her remodulin but thinks the covid was possibly contributing to that as well.Patient states that her tubing last night was ?leaking? and had to be changed, but that patient did not have any interruption in therapy because medication from tubing was still infusing and never depleted.No issues from yesterday's tubing incident.Patient states that she is doing better since having covid, not completely 100 percent but better, and that she is tolerating her remodulin increases with no issues and feels that it is helping with her pulmonary arterial hypertension symptoms.No other side effects.Product problem with the "cracked" tubing, patient does not have it saved.Additional information received by smiths medical/icu on 8-dec-2022 via email and attached to complaint object: patient details updated in the complaint.

Manufacturer Narrative

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 reportable information becomes available.

• Brand Name: CADD EXTENSION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section G): NULL
• MDR Report Key: 16022710
• MDR Text Key: 308120030
• Report Number: 3012307300-2022-28049
• 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 Health Care Professional
• Type of Report: Initial
• Report Date: 12/21/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/05/2022
• 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: 48 YR
• Patient Sex: Female