MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HL-20 INTEGRATED PERFUSION SYSTEM; CONSOLE, HEART/LUNG MACHINE

Model Number MCP00706193

Device Problems Increased Pump Speed (1501); Pumping Stopped (1503); Device Displays Incorrect Message (2591)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/06/2011

Event Type  malfunction  

Event Description

On (b)(6) 2011, at (b)(6), the customer reported that for the vario single hl20 4-pumps (b)(4) when the power switch for the pump module is turned on, and the pump module rpm adjust knob is off (not used), the pump motor and rotor begin to turn very fast, up to 250 rpm then abruptly stops and gives an error message.The hospital reported this to the maquet service representative on (b)(6) 2011.(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) provides product failure investigation, analysis, and resolution for the device described in this report.The service technician traced the problem to the motor control board.The motor control board was replaced with a new board.The defective board was not returned to the manufacturer.(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART/LUNG MACHINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4283279
• MDR Text Key: 5226592
• Report Number: 8010762-2014-00523
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2011

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00706193
• Device Catalogue Number: 70104.3261
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Event Location: Hospital
• Date Report to Manufacturer: 10/17/2011
• Date Manufacturer Received: 10/17/2011
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1