MAQUET HL-20 TWIN PUMP
Received Nov 26, 2014 · Event occurred Nov 4, 2011
Report 8010762-2014-00549 · MDR key 4280460
Device
Generic name
Flowmeter, Blood, Cardiovascular
Manufacturer
Maquet Cardiopulmoary AgModel number
MCP00703323Catalog number
70103.5075
Product problems
- Out-Of-Box Failure
- Defective Device
Patient
Not reported
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
(B)(4). MAQUET CARDIOPULMONARY PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEFECTIVE LED WAS REPLACED. (B)(4).
Description of Event or Problem
ON (B)(4) 2011, THE EQUIPMENT DISTRIBUTOR, (B)(4), WAS INSTALLING A NEW HL20 AT (B)(6) MEDICAL CENTER. THE DISTRIBUTOR REPORTED THAT DURING THE INSTALLATION OF THE TWIN PUMP MODULE TPM 20-330 TWIN ROLLER PUMP (ARTICLE NUMBER: (B)(4), SERIAL NUMBER: (B)(4)) THAT THE LED SWITCH ON THE RIGHT SIDE OF THE TPM WAS DEFECTIVE. THE DISTRIBUTOR REPORTED THE EVENT TO THE MAQUET SERVICE TECHNICIAN ON (B)(4) 2011. (B)(4).