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

Device Problem Connection Problem (2900)

Patient Problems Diarrhea (1811); Headache (1880); Swelling/ Edema (4577)

Event Type  malfunction  

Manufacturer Narrative

No product or photographic evidence were provided to aid in this investigation.The complaint report offered insufficient details to determine whether this product functioned as intended, or was used in a manner consistent with its instructions for use (ifu) or failed to meet product specifications.Lacking any additional evidence, this complaint has been closed as unconfirmed.If the product is returned, smiths medical will reopen this complaint for further investigation.No lot number provided for dhr.

Event Description

It was reported that the patient reported occasional shortness of breath, fatigue and swelling in her legs, feet and hands.Patient advised she can tell improvement in how she feels since starting remodulin.Pt has had 1 day of diarrhea and occasional headache since starting remodulin.Patient reported she has clots in her legs and lungs and hopes to get well.Enough to have surgery to remove them.Pt reported her cassettes have been going haywire but she called to our nursing line last night and they were able to troubleshoot and correct issue.No further details provided.

• Brand Name: CADD MEDICATION CASSETTES
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer (Section G): ST PAUL; 1265 grey fox rd.; st. paul MN 55112
• Manufacturer Contact: jim vegel ; 6000 nathan lane north; minneapolis, MN 55442
• MDR Report Key: 14161310
• MDR Text Key: 289670794
• Report Number: 3012307300-2022-06728
• 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: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Sex: Female
• Patient Weight: 67 KG