MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. TUBING; SET, ADMINISTRATION, INTRAVASCULAR

Patient Problems Diarrhea (1811); Headache (1880); Tachycardia (2095)

Event Type  malfunction  

Event Description

Veletri dose or amount: approximately: 13.593 ng/kg/min.Pt reported today she was due to switch pumps at her 4pm change and she immediately started experiencing side effects.Headache and heartrate went up to 128 beats per minutes.She had diarrhea as well.Pt reported this was at 4pm today.Pt reports she switched pumps back to the backup pump and the issues went away within 15 minutes.No change in dose.Still some diarrhea, but greatly improved.Heartrate back down to 90 beats per minute and pt is feeling better.(adverse event for veletri reported separately).Pt states that two days ago she noticed a leak with pump and tubing was cracked.Pt states she changed the tubing and got a headache and felt like she was going to die (adverse event reported for veletri at the time but pt did not report on tubing or pump) lot number and expiration date for tubing: unknown.Part number for tubing: unknown.Serial number for pump: unknown.Pump return tracking information not available.Photographs were not provided.This is a continuous infusion.Set flow rate and volume delivered are unknown.Position of the pump when alarm occurred and/or when issue was identified is unknown.No further info.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to patient or clinical injury? yes, pt reported diarrhea/headache/increased heart rate all which resolved or almost completely resolved after pt switched to backup pump.No additional medical intervention required.Is the actual device available for investigation? pump, yes.Tubing, no.Did we replace device? pump replaced and pt had tubing on hand.Did the patient have a backup device they were able to switch to? pump and tubing, yes.Infusion is the infusion life-sustaining.What is the outcome of the event? resolved.No further info, dates or timelines known.Reported to (b)(6) by: patient/caregiver.Reference report: mw5148922.

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 18282372
• MDR Text Key: 330051509
• Report Number: MW5148923
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Is the Reporter a Health Professional?: Yes
• Patient Sequence Number: 1
• Treatment: CADD LEGACY PUMP INFUSION.; SODIUM CHLOR INJ (1000ML/BAG).; VELETRI SDV.
• Patient Sex: Female