MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HEART LUNG MACHINE- HL20; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number MCP00703309

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

September 04, 2015 09:51 am (gmt-4:00) added by (b)(6): (b)(4).A maquet service technician evaluated the device and could not reproduce the reported issue.The device is being returned to the repair depot and a loaner device is being provided.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

It was reported that the customer received the message rpm-diff and the pump would not work on some occasions.No reported patient effect.(b)(4).

Manufacturer Narrative

(b)(4).Field safety technician has been sent for investigation and could not duplicate issue - operated unit for one week with numerous warm and cold starts, checked calibration including belt tension and tacho phase,no issues found.Calibration and functional test as per the service manual.It was decided to replace the motor control board as a precaution.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.

Event Description

(b)(4).

• Brand Name: HEART LUNG MACHINE- HL20
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): MICHAEL CAMPBELL; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437
• MDR Report Key: 5057001
• MDR Text Key: 25738323
• Report Number: 8010762-2015-01035
• 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,Followup
• Report Date: 08/05/2015

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: MCP00703309
• Device Catalogue Number: 701027652
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/07/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/05/2015
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/30/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2013
• 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