MAUDE Adverse Event Report: AMBIT AMBIT PCA AMBULATORY PUMP; PUMP, INFUSION, PCA

Device Problem Defective Component (2292)

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

Event Type  malfunction  

Event Description

The patient reported that an ambit pca ambulatory infusion pump was being used for a trial.The green light on the external pump was not on and it was turned up to 11.600219789.This report reflects information received by fda in the form of a notification per 803.22 (b)(2).

• Brand Name: AMBIT PCA AMBULATORY PUMP
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): AMBIT
• MDR Report Key: 17526892
• MDR Text Key: 321170584
• Report Number: MW5133829
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/11/2013

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: 08/12/2023
• Patient Sequence Number: 1