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

Model Number 21-7106-24

Device Problems Device Alarm System (1012); Increase in Pressure (1491)

Patient Problems Anemia (1706); Pulmonary Hypertension (4460)

Event Type  malfunction  

Event Description

It was reported that the iv treprostinil, patient was in hospital for a week.Date of admission and discharge not provided.White blood count went down, possibly side effects of other medication she is on.Patient was retaining a lot of fluid - around 10-11 pounds, in over a week.Patient is titrating now to improve symptoms of pulmonary arterial hypertension, tiredness.Patient has anemia and last night patient reported lump on the right leg.No lump now after wearing compression socks.Patient also reported that she had problem with tubing- she had high-pressure alarm caused by tubing twice in the last 2 weeks.Confirmed tubing attached in the right way, filter position the same as always but there was problems with clamps and medication was not flowing freely.The reported product did not fault occur while in use with the patient.The product issue did not cause or contribute to patient or clinical injury.The patient able to continue their infusion.The infusion is a lifesaving.

Manufacturer Narrative

Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, icu medical will reopen this complaint for further investigation.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Manufacturer Narrative

Other text: no lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• Brand Name: CADD EXTENSION 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: 17368341
• MDR Text Key: 319933594
• Report Number: 3012307300-2023-07438
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10610586023279
• UDI-Public: 10610586023279
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K974013
• 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: 01/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/20/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 21-7106-24
• Device Catalogue Number: 21-7106-24
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/05/2024
• 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 Sex: Female