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

Model Number MCP00703309

Device Problems Device Displays Incorrect Message (2591); Unintended Movement (3026)

Patient Problem No Patient Involvement (2645)

Event Date 12/03/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

As stated by the field service technician: ""i faced a problem which is related to rpm drive.After turning on the rpm drive, without any other action, the pump suddenly starts to rotate very fast and s-stop error is seen and the pump stops." no patient involvement.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).As stated by the field service technician the issue could be solved by replacing the motor control board.Despite several requests further information about service documents and part return have not been received.Thus no investigation could be performed.The root cause could not be determined.The failure could not be confirmed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.

Event Description

Internal reference: (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
• MDR Report Key: 8170314
• MDR Text Key: 130786529
• Report Number: 8010762-2018-00329
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MCP00703309
• Device Catalogue Number: 70102.7652
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1