MAUDE Adverse Event Report: SMITHS MEDICAL ASD INC RESERVOIR, MED CASSETTE; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 21-7302-24

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/02/2019

Event Type  malfunction  

Event Description

Spontaneous call from patient, stating that two of her cadd-legacy pumps (serial numbers unk) for iv remodulin both had the same error message (patient still has another pump infusing; no interruption in therapy): "no disposable, pump won't run".Informed patient that it might be a possible defective cassette, and to try a new cassette to see if she has any further issues.Most likely patient did not save cassette.Patient did not call back after several hours.Did the reported product fault occur while in use with a patient? no.Did the product issue cause or contribute to patient or clinical injury? no.Is the actual device is available to be returned for investigation - single isolated incident.Not replaced.Patient has more.Reported to (b)(6) by: patient/caregiver.

• Brand Name: RESERVOIR, MED CASSETTE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): SMITHS MEDICAL ASD INC
• MDR Report Key: 8420631
• MDR Text Key: 138895353
• Report Number: MW5084889
• Device Sequence Number: 1
• 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: 03/02/2019
• 3 Devices were Involved in the Event: 1 2 3

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 21-7302-24
• Device Lot Number: 3745652
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 44 YR