MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. CASSETTE MEDICATION RESERVOIR; SET, I.V. FLUID TRANSFER

Lot Number 4321040

Device Problems Nonstandard Device (1420); Insufficient Flow or Under Infusion (2182)

Patient Problem Pulmonary Hypertension (4460)

Event Type  Injury  

Event Description

Patient reported she had cassette packaging from last months shipment with lot number 4321040, expiration date unknown.Patient used all 30 cassettes from this previous order/lot number and is currently infusing with a newer lot number that is unaffected.Patient did report an increase in pulmonary hypertension symptoms this past month which required her to seek medical attention and visit her prescriber.Patient's husband also stated that it seemed like her cassettes had a lot more medication left over (more than half full) when it was time for a cassette change.Patient states there have not been any alarms or alerts displaying on her pump.Pharmacy will inform md office as patient may have been receiving subtherapeutic dose.No further information available.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? yes.Is the actual product available for investigation? no.Reported to (b)(6) by pt/caregiver.

• Brand Name: CASSETTE MEDICATION RESERVOIR
• Type of Device: SET, I.V. FLUID TRANSFER
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.; minneapolis MN
• MDR Report Key: 16086060
• MDR Text Key: 306608429
• Report Number: MW5114105
• Device Sequence Number: 1
• 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: 12/16/2022
• 30 Devices were Involved in the Event: 1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Lot Number: 4321040
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: EPOPROSTENOL
• Patient Sex: Female