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

Device Problems Device Alarm System (1012); Inaccurate Delivery (2339); Improper Flow or Infusion (2954)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/27/2023

Event Type  malfunction  

Manufacturer Narrative

A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.

Event Description

It was reported disposable caused the pump to alarmed completed.The time was correct for the infusion.When the nurse disconnected the pump there was significant drug left in the infusion bag.Pump settings were verified at 23.5ml/hour for 540 mls.Pharmacist and nurse manager decision made to infuse remaining drug at 23.5ml/hour.Remaining drug was 35-40mls and this was infused over a little under 2 hours.Caused delays in patient care and concern that cadd pump/ cassette was infusing medication too slowly.No patient injury reported.

Manufacturer Narrative

Other, other text: no product was returned.We are unable to confirm the reported complaint.If the product is returned, this complaint will be reopened for further investigation.No lot number was provided; therefore, a device history record (dhr) review could not be conducted.

• 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: 16573627
• MDR Text Key: 311602728
• Report Number: 3012307300-2023-02706
• 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: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 02/27/2023
• Initial Date FDA Received: 03/20/2023
• Supplement Dates Manufacturer Received: 06/26/2023
• Supplement Dates FDA Received: 06/28/2023
• 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 Age: 67 YR
• Patient Sex: Female