MAUDE Adverse Event Report: PUMP; PUMP, INFUSION

Device Problems Nonstandard Device (1420); Output Problem (3005)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Type  Injury  

Event Description

Daughter also informed author that back in october pt was in the hospital [unknown dates] due to the cassette issues (unknown lot numbers of cassettes used at time of hospitalization),she says the pump kept alarming and pt was changing it but also experiencing pah symptoms.The md at the hospital thought the pt wasn't getting all of her medication and maybe it was a cassette issue.Turns out these cassettes may have been part of the recall.No further info at this time.Pt was able to switch cassettes without issue or interruption in therapy.Hospitalization was due to pah symptoms not due to inability to receive medication from her pumps/cassettes.Product lot number and expiration date were systematically retrieved from the dispensing system.Reported to (b)(6) by pt/caregiver.

• Brand Name: PUMP
• Type of Device: PUMP, INFUSION
• MDR Report Key: 16069624
• MDR Text Key: 306434237
• Report Number: MW5114078
• Device Sequence Number: 2
• Product Code: LHI
• 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: 12/15/2022
• 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?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 12/28/2022
• Patient Sequence Number: 1
• Treatment: TADALAFIL
• Patient Outcome(s): Hospitalization
• Patient Sex: Female