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

Model Number MCP00917741

Device Problems No Display/Image (1183); Pumping Stopped (1503)

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

Event Date 10/25/2018

Event Type  malfunction  

Manufacturer Narrative

A field service technician has been sent out for investigation but the failure could not be reproduced.The investigation is still ongoing.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported that the display of the arterial pump (single roller pump) went off and the pump stopped during patient treatment (mitral and tricuspid valve replacement).In order to maintain the blood flow, the pump was operated with hand crank and then replaced with another single roller pump.All pumps worked fine afterwards.According to the received information, the patient is not good.No further information available at the moment.(b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).Contact person: (b)(6).A field service technician was sent out for investigation on 2018-10-26.The technician opened the pump and noticed that the guiding cylinder of the pump was loose.Cylinder was fixed and the device was checked as required by service protocol.No safety or function defects were detected.In addition the device was switched on/off for several times, different modes were tested and the connection between console and pump, as well as the switch of the pump was checked.The failure could not be reproduced and no parts were replaced.Therefore no further investigation could be performed in our laboratory and no most probable root cause could be determined.Thus the failure could not be confirmed.However, if the loose guiding cylinder dropped inside the pump, it could have created a short and caused the pump to stop (stated by life cycle engineering).The technician was contacted in order to clarify where the cylinder was found.The hospital was contacted several times in order to received further information about the incident.However, the only information received was that the patient is getting better and its condition is not life threatening.Besides that, no feedback from the hospital was received.Therefore it is unclear whether the pump stop was responsible for the patients condition or if it was caused by other circumstances.

Event Description

Internal reference: (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, 45 barbour pond drive, wayne, nj 07470.Contact person- (b)(4).The field service technician confirmed that he found the guiding cylinder within the pump, which might create a short and caused the failure.Thus the failure could be confirmed.The most probable root cause could be determined.The screw which tighten the guiding cylinder was loosen.(to refer to the life cycle engineering´s statement: if the loose guiding cylinder dropped inside the pump, it could have created a short and caused the pump to stop).

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: 8041738
• MDR Text Key: 126513127
• Report Number: 8010762-2018-00296
• 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,Followup
• Report Date: 01/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• 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
• Initial Date Manufacturer Received: 10/26/2018
• Initial Date FDA Received: 11/06/2018
• Supplement Dates Manufacturer Received: 10/26/2018; 10/26/2018
• Supplement Dates FDA Received: 12/19/2018; 01/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention