MAUDE Adverse Event Report: GAMBRO AB RENAL PRODUCTS, INC. PRISMAFLEX; HEMODIALYSIS UNIT

Model Number 107493

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/02/2016

Event Type  malfunction  

Event Description

Prismaflex repeatedly alarmed set disconnected, pressure drop and tmp were negative numbers.Called gambro rep and instructed on problem solving strategies.Unable to diagnose if issue was related to set or machine, advised per rep to get a new set and machine to be sure.Blood was able to be given back to patient.Patient was not harmed from this incident.

• Brand Name: PRISMAFLEX
• Type of Device: HEMODIALYSIS UNIT
• Manufacturer (Section D): GAMBRO AB RENAL PRODUCTS, INC.; 9540 maroon cir fl 4; englewood CO 80112
• MDR Report Key: 6296727
• MDR Text Key: 66376703
• Report Number: 6296727
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: 107493
• Device Catalogue Number: 113081
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/28/2016
• Event Location: Hospital
• Date Report to Manufacturer: 12/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 57 YR
• Patient Weight: 98