MAUDE Adverse Event Report: UNK SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Device (2588)

Patient Problems Dyspnea (1816); Swelling/ Edema (4577)

Event Date 08/08/2021

Event Type  Injury  

Event Description

Patient stated had site change & pump change (b)(6) 2021 & had blood in tubing.(b)(6) 2021 pt woke up and the blood was gone from the tubing & there was no alarm.However, her normal pain she gets from infusion was completely gone.(b)(6) 2021 patient experienced worsening in breathing.Pt saw md & was told that pulmonary pressure was high but they could not help her with the pump or tubing.However, they gave her diuretics to help with her swelling.Per pt, she rotated the pump yesterday & changed to a new site yesterday and had no issues since then with her pump & tubing.It seems that she is getting the medication now & breathing is better than before.Patient not sure if the issue was with pump serial number (b)(4) and it just did not deliver drug & did not alarm or something else.Sending new pump for malfunction.Did the reported product fault occur while in use with the patient? yes.Did the product issue cause or contribute to pt or clinical injury? yes.Swelling and difficulty breathing, was any medical intervention provided? yes.Mc provided pt with diuretic.Is the actual device available for investigation? yes.Device serial number is (b)(4).Did we replace the device? yes.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.What is the outcome of the event? resolved.No other info provided at this time.Reported to (b)(6) pt/caregiver.

• Brand Name: SET, ADMINISTRATION, INTRAVASCULAR
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): UNK ; unk MN
• MDR Report Key: 12331581
• MDR Text Key: 267242634
• Report Number: MW5103278
• 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: 08/12/2021
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/16/2021
• 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
• Patient Sequence Number: 1
• Patient Age: 61 YR