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

Device Problem Leak/Splash (1354)

Patient Problems Fatigue (1849); Headache (1880); Nausea (1970); Vomiting (2144); Dizziness (2194); Malaise (2359); Diaphoresis (2452); Pallor (2468)

Event Type  malfunction  

Event Description

It was reported that during infusion with a pump delivering intravenous (iv) remodulin at 150ng/kg/min, the patient experienced tubing leakage leading to a lack of iv remodulin delivery.The patient ?just didn?t feel right all day? with symptoms such as paleness, clamminess, lightheadedness, and an inability to complete their pulmonary rehab routine.Initially the patient attributed these symptoms to a dosage increase of another medication; however, it was later discovered that remodulin had leaked onto the patient?s shirt due to leakage that was at the round white filter of the tubing.Concerns were raised about the sterility of remodulin infusing through compromised tubing directly into the bloodstream.The patient experience severe nausea, vomiting, and headaches, even with pre-medication.Unspecified medical intervention was provided.The patient was able to successfully continue therapy with a backup product.

Manufacturer Narrative

Other, other text: b3: unknown; no information has been provided to date.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

G2 email is: (b)(4).No product was returned.The reported complaint could not be confirmed.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.

• Brand Name: CADD ADMIN SETS
• 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: 18046630
• MDR Text Key: 327048764
• Report Number: 3012307300-2023-10108
• 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,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/03/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2023
• 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: 12/06/2023
• 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
• Patient Sex: Female
• Patient Weight: 127 KG