MAUDE Adverse Event Report: HOSPIRA HOSPIRA; LIFECARE PCA PUMP

Model Number CUSTOM DWL-AB132

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/19/2014

Event Type  malfunction  

Event Description

Rn entered room to check on pt pca was flashing malfunction on screen then screen went blank.Rn was unable to retrieve how much medication (morphine) pt had received up to that point.Pca discontinued and removed from service.No harm to pt.

• Brand Name: HOSPIRA
• Type of Device: LIFECARE PCA PUMP
• Manufacturer (Section D): HOSPIRA; 275 north field drive; dept 361, bldg h1; lake forest IL 60045
• MDR Report Key: 3692991
• MDR Text Key: 21239165
• Report Number: MW5035068
• 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: 02/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CUSTOM DWL-AB132
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 67 YR