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

Model Number 70102.8580

Device Problem Pressure Problem (3012)

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

Event Date 10/14/2019

Event Type  malfunction  

Manufacturer Narrative

The getinge field service technician was onsite to perform initial investigation.It was not possible to reproduce the reported failure.Root cause analysis is ongoing.A supplemental medwatch will be submitted after new information has been received.

Event Description

In (b)(6) it was stated that during perfusion with hl20 unit, a pump stop was triggered by pressure 1, according to the cardiologist.Arterial pump stopped for approx.15 min.It was further pumped to manual mode, after resetting the machine, the pump could be restarted normally.A negative pressure of -999 mmhg was displayed.No patient harm was stated.(b)(4).

Manufacturer Narrative

According to service order# 43152329 dated on 2019-10-16 the technician performed as follows: replaced pressure module 1&2 70105.3595 sn#(b)(6) and pressure module 3&4 70105.3596 sn# (b)(6).Electrical safety tests, full inspection, full functional tests.Unit passed all tests.The defective dual pressure module (dpm) were requested multiple times for investigation.The dpm was requested with rma#40462 on 2020-02-17.Parts were received on 2020-03-20.Lce performed the investigation according to report #(b)(4) on 2020-06-22 as follows: a dual pressure module (dpm) for each of the channels 1+2 (mat-no.701010841, (b)(4)), in the following referred as dut1, and 3+4 (mat-no.701010842, (b)(6)), in the following referred as dut2, were received for investigation.No pressure connection cables or pressure sensors were delivered.Since it is a known cause of error for the display of extreme measured values when the contact between the dpm and the sensor is disturbed (att.7.1), the socket contacts of all 4 sensor connections were visual inspected.No abnormalities were found.The contacts are securely seated in the interlocks.A contact problem on the side of the sensor sockets of the duts can therefore be excluded as a cause of error.The housing of dut1 has been removed to evaluate the service interface.Therefore dut1 was installed in a hl20 and put into operation.Via the service interface the measured values and error messages are shown every second and recorded on a pc.During the first test operation of approx.12 hours, no abnormalities were detected in the monitoring.The measured values were stable and no error message was displayed the reported failure could not be observed during the investigation.Therefore the failure could not be confirmed.Possible causes of the reported failure: defects (cable break, bent or broken pins, etc.) on the sensor cable or sensor itself.Mechanical defect of the sensor socket on the dpm.Electrical defects within the dpm.The reported failure happened during patient treatment.The hl20 in question was responsible for this complaint/event.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Reference number: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9273243
• MDR Text Key: 192163107
• Report Number: 8010762-2019-00347
• 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,o
• Type of Report: Initial,Followup
• Report Date: 06/24/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: 70102.8580
• Device Catalogue Number: MCP00917741
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 10/15/2019
• Initial Date FDA Received: 11/04/2019
• Supplement Dates Manufacturer Received: 06/22/2020
• Supplement Dates FDA Received: 06/24/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1