MAQUET HL-20 TWIN PUMP
Received Nov 26, 2014 · Event occurred Nov 4, 2011
Report 8010762-2014-00539 · MDR key 4280436
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 AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE DEFECTIVE LED WAS REPLACED. REFERENCE: (B)(4).
Description of Event or Problem
ON (B)(4) 2011, THE EQUIPMENT DISTRIBUTOR, MEDTRONIX MEDICAL SUPPLIES, (B)(4), WAS INSTALLING A NEW HL20 AT (B)(6). THE DISTRIBUTOR REPORTED THAT DURING THE INSTALLATION OF THE TWIN PUMP MODULE TPM 20-330 TWIN ROLLER PUMP (ARTICLE 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. REFERENCE: (B)(4).