MAUDE Adverse Event Report: HOSPIRA, INC. LIFECARE PCA; PUMP, INFUSION, PCA

Model Number 1427928

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problem Underdose (2542)

Event Date 08/01/2020

Event Type  malfunction  

Event Description

Hub securement connector broke and tubing became disconnected from the patient.The patient did not receive the correct dose of fentanyl and propofol.Lot number not known.

• Brand Name: LIFECARE PCA
• Type of Device: PUMP, INFUSION, PCA
• Manufacturer (Section D): HOSPIRA, INC.; highway 301 north; rocky mount NC 27801
• MDR Report Key: 10670157
• MDR Text Key: 211034191
• Report Number: 10670157
• Device Sequence Number: 1
• Product Code: MEA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 1427928
• Device Catalogue Number: 1427928
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 09/11/2020
• Event Location: Other
• Date Report to Manufacturer: 10/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 13870 DA