MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MEDFUSION 4000 ROTATING POLE CLAMP; ACCESSORIES, PUMP, INFUSION

Device Problem Break (1069)

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

Event Date 08/21/2021

Event Type  malfunction  

Event Description

Patient in isolette that has a pole attached to it for attaching pumps.Rn, rcp (respiratory care practitioner), and patient's mother at bedside performing hands-on care when one of patient's medfusion pumps suddenly snapped/broke off at the site where the pump can slide on and off of the clamp.Rn was able to catch the pump before it fell all the way to the floor.Patient has a peripherally inserted central catheter (picc) line and the patient's medline with saline flush syringe was attached to that pump but not infusing at that time.Medfusion pump was taken to be red tagged and staff picked up the pump.Please note that the clamp is a separate non-serialized part from the pump.There was no harm in this event and this is not a recurring event.

• Brand Name: MEDFUSION 4000 ROTATING POLE CLAMP
• Type of Device: ACCESSORIES, PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; 6000 nathan lane north; minneapolis MN 55442
• MDR Report Key: 12445815
• MDR Text Key: 270551283
• Report Number: 12445815
• Device Sequence Number: 1
• Product Code: MRZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/26/2021
• Date Report to Manufacturer: 09/09/2021
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 19 DA