MAQUET CARDIOPULMONARY AG
Received Oct 8, 2013 · Event occurred Sep 11, 2013
Report 8010762-2013-00051 · MDR key 3459119
Device
Generic name
Hl 20 4-pumps Console Base
Manufacturer
Maquet Cardiopulmonary AgModel number
70102.8580Lot number
NA
Product problems
- Occlusion Within Device
- Pre Or Post-Pumping Problem
- Improper or Incorrect Procedure or Method
Patient
7 YR
- No Patient Involvement
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER FELT THEY HAD OVER OCCLUDED THE ROLLER ON A TWIN ROLLER PUMP WHICH CAUSED THE PUMP TUBING TO RUPTURE. THIS EVENT OCCURRED POST SUPPORT/BYPASS SO THERE WAS NO PATIENT EFFECT. (B)(4).
Additional Manufacturer Narrative
MAQUET MEDICAL SYSTEMS, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). MAQUET CARDIOPULMONARY (B)(4) PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE IFU FOR THE HL20 DESCRIBES HOW TO CHANGE THE OCCLUSION OF THE PUMP. IT IS NOTED IN THE IFU THAT AN INCORRECTLY ADJUSTED OCCLUSION CAN INFLUENCE THE LIFE TIME OF A TUBE.