HL-20 TWIN PUMP
Received Jul 28, 2015 · Event occurred Oct 11, 2013
Report 8010762-2014-00921 · MDR key 4944785
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Maquet Cardiopulmonary AgModel number
70102.8692Catalog number
MCP00703277
Product problems
- Electrical /Electronic Property Problem
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2013 AT THE (B)(6), IT WAS REPORTED THROUGH THE MSUPPORT SYSTEM COMPLAINT NUMBER (B)(4) THAT THE MOTOR CONTROL BOARD AND CONTROL BOARD ON THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) WERE DEFECTIVE AFTER THE UNIT WAS UPGRADED TO SOFTWARE VERSION 2.5. THE SSU REPORTED THAT THE UNIT DISPLAYED AN A/D CONVERTER (+5V ERROR). (B)(4).
Additional Manufacturer Narrative
MAQUET MEDICAL SYSTEM, USA SUBMITS THIS REPORT ON BEHALF OF THE LEGAL MANUFACTURER OF THE DEVICE MAQUET CARDIOPULMONARY (B)(4). THE DEVICE WAS EVALUATED BY A SSU TECHNICIAN AND THE MOTOR CONTROL BOARD AND CONTROL BOARD WERE FOUND TO BE DEFECTIVE AND WERE REPLACED (B)(4).