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

Model Number RPM 20-320

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

Patient Problem No Patient Involvement (2645)

Event Date 02/28/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Field safety technician has been sent for in investigation, verified the no comm error and troubleshot system.It was determined the control board was defective.According to service order# (b)(4) the control board has been replaced.Also the service technician calibrated flow setting for use.The unit passed all functional and safety tests per factory specifications and has been already returned to customer and cleared for clinical use.The defective control board has been requested by manufacturer for further investigation.A supplemental medwatch will be submitted when new information has been received.

Event Description

As stated by the customer: a single pump of a hl20 would display communication error on screen at power up.No patient was involved.(b)(4).

Manufacturer Narrative

(b)(4).Field safety technician has been sent for investigation, verified the no comm error and troubleshoot system.It was determined the control board was defective.According to service order# (b)(4) the control board has been replaced.Also the service technician calibrated flow setting for use.The unit passed all functional and safety tests per factory specifications and has been already returned to customer and cleared for clinical use.The defective control board was returned for further investigation.According to investigation report# (b)(4) by life cycle engineering (maquet-rastatt) the control board (dut) was mounted into a hl20.The no com error could be reproduced.It has been detected that the odu connection was working properly.Only the communication via the din-bus was interrupted.One or more defective solder points (user error) caused most probable the interrupted communication via din-bus.Thus the failure could not be confirmed.The control board cannot be re-used.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

(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: 6391140
• MDR Text Key: 69812873
• Report Number: 8010762-2017-00075
• 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: 07/10/2017

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: RPM 20-320
• Device Catalogue Number: MCP00702885
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2017
• Initial Date FDA Received: 03/09/2017
• Supplement Dates Manufacturer Received: 02/28/2017
• Supplement Dates FDA Received: 07/10/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2005
• 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