MAUDE Adverse Event Report: IV LINE; SET, ADMINISTRATION, INTRAVASCULAR

Device Problems Fluid/Blood Leak (1250); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems Muscle Weakness (1967); Dizziness (2194)

Event Date 04/13/2021

Event Type  Injury  

Event Description

Spontaneously patient called and reported an issue with her pump (b)(4).She stated that she awoke around 4 am and was wet because her pump had been leaking.Patient had called the pharmacy earlier in the morning and was advised to make a new cassette and use backup pump, but patient stated that her husband mixes her cassettes, so she was going to call him to do so.Per patient this didn't occur till 11 am.Patient was potentially off her remodulin for an unknown period of time.It is unclear where the leak was occurring.Patient added that her iv line got tugged a few days ago and a few stitches fell out.Patient reports she is feeling somewhat weak and dizzy.Patient also reporting twitching in hands.Notified md office.No other information or dates available.If yes, was any medical intervention provided? no; is the actual device available for investigation? yes; did we[mfr] replace device? yes.Did the pt have a back up device they were able to switch to? yes.Was the pt able to successfully continue their infusion? yes.Is the infusion life-sustaining? yes.Outcome of event - resolved.Did the reported product fault occur while in use with the pt? yes.Did the product issue cause or contribute to pt or clinical injury? yes.If yes, was any medical intervention provided? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: IV LINE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 11693025
• MDR Text Key: 246481097
• Report Number: MW5100851
• Device Sequence Number: 2
• 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: 04/14/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/19/2021
• Patient Sequence Number: 1
• Patient Age: 56 YR