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

Model Number MCP00917741

Device Problems Device Displays Incorrect Message (2591); Communication or Transmission Problem (2896)

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

Event Date 02/05/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4), (b)(6).Field safety engineer was sent for investigation.He could not reproduce reported problem of "loss of communication" while running twin pump ( serial number (b)(4)) (free running/card ) respectfully.Although, error code "em07" indicated on scp module.Adjusted 5v reference voltage error message still present.Dis-assembled scp module, removed ribbon cable and re-connected a few times, error message removed.Operational and safety tested.Thus failure could not be confirmed.This data will be handled through a designated maquet trending process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

(b)(4).Customer stated device alarmed and lost communication with monitor and pump, em07 error message.(b)(4).

• Brand Name: HL-20 INTEGRATED PERFUSION SYSTEM
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 5477023
• MDR Text Key: 39809738
• Report Number: 8010762-2016-00133
• Device Sequence Number: 1
• Product Code: DTQ
• Combination Product (y/n): N
• PMA/PMN Number: K943803
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/09/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00917741
• Device Catalogue Number: 701028580
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/09/2016
• Initial Date FDA Received: 03/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2011
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1