MAUDE Adverse Event Report: BAXTER BARD PCA II; PCA PUMP

Model Number 2L3104

Device Problems Inadequate Instructions for Healthcare Professional (1319); Component Missing (2306); Difficult to Open or Close (2921); Programming Issue (3014)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2014

Event Type  malfunction  

Event Description

Difficulty opening door on pump; pump would not accept infusion order of less than 0.2mg.When priming tubing, pump locked pt; out and did not allow pt to obtain medication through pump for 30 minutes, even though tubing was just primed and dosed entered into pump.No operations manual available to troubleshoot pump.Key to door pump not working effectively.Pump replaced by uhs - second pump same issue.This is an old baxter pump.Returned to uhs, bio-med vendor for evaluation/testing/repair.Outcome pending.

• Brand Name: BARD PCA II
• Type of Device: PCA PUMP
• Manufacturer (Section D): BAXTER; deerfield 60015
• MDR Report Key: 4199002
• MDR Text Key: 5148428
• Report Number: MW5038757
• Device Sequence Number: 1
• Product Code: MEA
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 10/17/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2L3104
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/17/2014
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 63 YR