MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC. MS3 PUMP CADD; PUMP, INFUSION

Device Problems Display or Visual Feedback Problem (1184); Therapeutic or Diagnostic Output Failure (3023)

Patient Problems High Blood Pressure/ Hypertension (1908); Rash (2033)

Event Date 04/01/2019

Event Type  Injury  

Event Description

Pt reports having a blistering rash around catheter site and whole and has been going on for about 6 weeks and is progressing.Md is aware and he is being treated for this.He also reports that his pump is malfunctioning.He says his systolic blood pressure went up to 140 while on the pump.He insisted to have pump replaced.No errors or alarms.We will replace pump and send return box.No interruption in therapy.Reported to (b)(6) by pt/caregiver.

• Brand Name: MS3 PUMP CADD
• Type of Device: PUMP, INFUSION
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.
• MDR Report Key: 8683125
• MDR Text Key: 147524662
• Report Number: MW5087207
• Device Sequence Number: 1
• Product Code: FRN
• 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: 05/31/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/07/2019
• Patient Sequence Number: 1
• Patient Age: 56 YR