HL-20 TWIN PUMP
Received Jul 28, 2015 · Event occurred Dec 19, 2013
Report 8010762-2014-00975 · MDR key 4944755
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Maquet Cardiopulmonary AgModel number
70103,5075Catalog number
MCP00703323
Product problems
- Device Displays Incorrect Message
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2013, AT THE (B)(6) HOSPITAL, (B)(6), IT WAS REPORTED THAT THE TPM 20-330 TWIN ROLLER PUMP MODULE SERIAL NUMBER (B)(4) DISPLAYED A HEAD ERROR ON THE RIGHT SIDE PUMP WHEN POWERED ON. THE DEVICE WAS REMOVED FROM SERVICE AND THE CUSTOMER WAS GIVEN A LOANER UNIT. THE NON-CONFORMITY REPORT INDICATES THAT THE FAILURE OCCURRED PRIOR TO USE ON A PATIENT. (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 UNIT WAS INVESTIGATED BY A SSU SERVICE TECHNICIAN AND THE OPTICAL TACHOMETER PCB WAS FOUND TO BE DEFECTIVE AND WAS REPLACED. (B)(4).