MAQUET HL-20 TWIN PUMP
Received Nov 26, 2014 · Event occurred Oct 21, 2011
Report 8010762-2014-00526 · MDR key 4280441
Device
Generic name
Flowmeter,blood, Cardiovascular
Manufacturer
Maquet Cardiopulmoary AgModel number
MCP00703279Catalog number
70102.8694
Product problems
- Device Displays Incorrect Message
- Inappropriate or Unexpected Reset
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2011, AT (B)(6), THE CUSTOMER REPORTED THAT AFTER THE TWIN PUMP MODULE TPM 20-330, TWIN ROLLER PUMP (ARTICLE NUMBER: 70102.8694, SERIAL NUMBER: (B)(4)) ATTACHED TO THE HL20 IS CONFIGURED AS CARDIOPLEGIA (LEFT PUMP) AND CARDIOPLEGIA-SLAVE (RIGHT PUMP) THAT OVER TIME THE CONFIGURATION THEN RETURNS TO THE DEFAULT FREE MODE. IN ADDITION, THE CARDIOPLEGIA-SLAVE HAS DISPLAYED AN "RPM-DIFF" ERROR MESSAGE. THE HOSPITAL REPORTED THIS TO THE MAQUET SERVICE REPRESENTATIVE ON (B)(6) 2011. (B)(4).
Additional Manufacturer Narrative
(B)(4). MAQUET CARDIOPULMONARY AG PROVIDES PRODUCT FAILURE INVESTIGATION, ANALYSIS, AND RESOLUTION FOR THE DEVICE DESCRIBED IN THIS REPORT. THE SERVICE TECHNICIAN CHECKED BOTH PUMP HEAD SPEEDS AND VERIFIED PUMP HEAD SPEEDS. THERE IS NO DOCUMENTATION THAT ANY REPAIR WAS PERFORMED. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. (B)(4).