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

Model Number MCP00706193

Device Problems Pumping Stopped (1503); Device Inoperable (1663)

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

Event Date 02/23/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, (b)(6), reported that on (b)(6) 2012 the control panel for the vario single hl20 4-pumps (b)(4) shut down during the operation and the pumps stopped.They used the hand crank for 25 minutes.(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 device was evaluated by the life cycle engineering (lce) group and determined that the control board master inside the control panel housing was defective.The root cause for why the control panel shut down could not be determined.The control board had blown fuses that stopped the operation of the panel and the master cpu.The pumps stopped because of the missing master communication.In addition, lce determined that the level bubble module (aep board) was defective.The service department replaced the master panel board and the aep board.The device was returned to service.(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: 4283407
• MDR Text Key: 15343504
• Report Number: 8010762-2014-00585
• 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
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 03/06/2012

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?: Yes
• 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?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Device Age: 3 MO
• Event Location: Hospital
• Date Report to Manufacturer: 03/06/2012
• Date Manufacturer Received: 03/06/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2011
• 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