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

Model Number MCP00151005

Device Problem Failure to Sense (1559)

Patient Problem No Patient Involvement (2645)

Event Date 04/03/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012, while performing incoming testing on a new, out of the box cls 20-535 capacitive level sensor (article number: 70101.0855, serial number: (b)(4)), at maquet medical systems service center, the service technician reported the the level sensor cable was defective.(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 level sensor cable was returned to maquet cardiopulmonary ag for further investigation.The investigation of the level sensor determined that the measured current on the level sensor was above the allowed range.The level sensor clamp was determined to be defective.(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: 4283409
• MDR Text Key: 5299176
• Report Number: 8010762-2014-00598
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Service and Testing Personnel
• Type of Report: Initial
• Report Date: 04/03/2012

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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: MCP00151005
• Device Catalogue Number: 70101.0855
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Device Age: 1 YR
• Event Location: Other
• Date Report to Manufacturer: 04/03/2012
• Date Manufacturer Received: 04/03/2012
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1