MAUDE Adverse Event Report: AVENT S. DE R.L. DE C.V. ELASTOMERIC PUMP (HOME PUMP C-SERIES); PUMP, INFUSION, ELASTOMERIC

Device Problems Inadequate or Insufficient Training (1643); Human-Device Interface Problem (2949); Positioning Problem (3009)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Other  

Event Description

Patient (b)(6) is scheduled to receive an at home infusion is 5-fu with an elastomeric pump (home pump c-series).The patient did not know the correct positioning of the pump from the catheter site.It is recommended that the pump be places approximately 40 cm (16 in) below the catheter site.The patient was planning to position the pump above this level which could have caused an increased flow rate in the medication.Increasing the flow rate of this medication could have caused various adverse effects for the patient.Strategies to mitigate these risks include having a trained home nurse there for the infusion to ensure that the pump is positioned and prepared appropriately.There could also be extensive patient training on these devices as well.(b)(6).

• Brand Name: ELASTOMERIC PUMP (HOME PUMP C-SERIES)
• Type of Device: PUMP, INFUSION, ELASTOMERIC
• Manufacturer (Section D): AVENT S. DE R.L. DE C.V.
• MDR Report Key: 17005295
• MDR Text Key: 316103840
• Report Number: MW5117878
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/24/2023
• Patient Sequence Number: 1