inforMED
MalfunctionDPW

HL-20 TWIN PUMP

Received Jul 28, 2015 · Event occurred Sep 5, 2013

Report 8010762-2014-00914 · MDR key 4944784

Device

Generic name

Flowmeter, Blood, Cardiovascular

Product problems

  • Device Displays Incorrect Message

Patient

Not reported

  • No Information

Narrative

Description of Event or Problem

ON (B)(6) 2013 IT WAS REPORTED BY THE (B)(4) AT MAQUET MEDICAL (B)(4) THROUGH THE MSUPPORT SYSTEM COMPLAINT NUMBER (B)(4) THAT THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) DISPLAYED A BELTSLIP ERROR WHEN RUNNING AT 250 RPM BUT THE DISPLAY INDICATED 119 RPM. THE RPM WAS MEASURED WITH AN EXTERNAL TACHOMETER AND IT INDICATED 119 RPM.

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 (B)(4) TECHNICIAN AND THE OPTICAL TACHO BOARD, MOTOR BELT AND BELT PULLEY WERE REPLACED AND THE ISSUE WAS RESOLVED. (B)(4).