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

Device Problem Increase in Pressure (1491)

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

Event Date 12/30/2022

Event Type  malfunction  

Event Description

Iv remodulin -spoke with patient, she informed me that she had high pressure alarm on one of her pumps today morning.She switched pumps and started new cassette and it was ok for a while and then high-pressure alarm was on again.Unknown lot number of the cassette that she was using and one that she switched to.Unk if problem was caused by pump, cassette er external blockage in her line.When she talked with me, everything was ok, infusion was not interrupted and patient was looking for a blockage or kink in the tubing and she finds none.Per patient she has her tubing attached in the right way (as usual).Advised if she will have high pressure alarm again, she will needs to go to hospital to fix her iv line, be it might be dislodged or may need repair.She verbally understood.No other information provided.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? no.Is the actual device available for investigation? no.Did we [mfr] replace the device? no.Did the pt have a backup device they were able to switch to? yes.If yes, was the pt able to successfully continue their infusion? yes.Is the infusion life sustaining? yes.Reported to (b)(6) by pt/caregiver.

• Brand Name: TUBING
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 16094763
• MDR Text Key: 306725003
• Report Number: MW5114150
• Device Sequence Number: 6
• Product Code: LHI
• Combination Product (y/n): N
• 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: 12/30/2022
• 6 Devices were Involved in the Event: 1 2 3 4 5 6

1 Patient was Involved in the Event

• Date FDA Received: 01/03/2023
• 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
• Patient Age: 43 YR
• Patient Sex: Female