MAUDE Adverse Event Report: CADD; SET, ADMINISTRATION, INTRAVASCULAR

Model Number FPA

Device Problem Mechanical Problem (1384)

Patient Problem Missed Dose (2561)

Event Date 08/12/2020

Event Type  malfunction  

Event Description

Information was received indicating that during use, a smiths medical cadd remote dose cord could not start working.It was also reported that the dose cord was retried with another pump but did not respond to button.Subsequently, the patient received doses through the pump's own button.It was noted that some bolus might have been missed before the issue was noted.No adverse effects were reported.

Manufacturer Narrative

Incident inadvertently reported.The malfunction not likely to cause or contribute to death or serious injury.The bolus dose cord is used for pca delivery only- any under-delivery for pca is not likely to result in death or serious injury.No patient death, no life-threatening event, no permanent impairment of a body function or structure, and no required medical or surgical intervention was needed to preclude serious impairment of a body structure or function.The product family hazard analysis indicates that the device in the reported incident is related to a hazardous situation and would not likely cause or contribute to a death or serious injury if the malfunction were to recur.

• Brand Name: CADD
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 10532064
• MDR Text Key: 207899441
• Report Number: 3012307300-2020-09279
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 10/07/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: FPA
• Device Catalogue Number: 21-2186-25
• Device Lot Number: 111-246-2-04
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1