HL-20 TWIN PUMP
Received Jul 28, 2015 · Event occurred Jul 31, 2013
Report 8010762-2014-00878 · MDR key 4944781
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 (B)(6), IT WAS REPORTED THROUGH THE SUPPORT SYSTEM COMPLAINT NUMBER 1071 THAT THE CONTROL BOARD ON THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) WAS DEFECTIVE AFTER THE UNIT WAS UPGRADED TO SOFTWARE VERSION 2.5. THE SSU REPORTED THAT THE UNIT DISPLAYED VARIOUS ERRORS. UPON REQUEST FOR FURTHER INFORMATION, THE SSU SAID THAT IT WAS NOT POSSIBLE TO OPERATE THE DEVICE IN A PROGRAM MODE (ONLY FREE MODE WAS AVAILABLE). (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 CONTROL BOARD WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. THE CONTROL BOARD WAS RETURNED TO MCP IN GERMANY FOR INVESTIGATION. DURING THE INVESTIGATION, THE DEVICE DISPLAYED A 'NO COMM' ERROR. THE CAUSE OF THE ERROR WAS DETERMINED TO BE A DAMAGED DC/DC CONVERTER. THE DAMAGE WAS CAUSED BY A MECHANICAL FORCE WHICH LIFTED TWO OF THE 8 PINS OF THE DC/DC CONVERTER. IT IS LIKELY THAT THE DAMAGE OCCURRED DURING THE SOFTWARE UPDATE WHERE THE CONTROL BOARD WAS PULLED OUT OF THE TPM HOUSING AND THE EEPROM IS CHANGED. (B)(4).