MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MCP00706195#VARIO TWIN, HL 20, 4-PUMPS; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number 701043267 - HL 20

Device Problem Pumping Stopped (1503)

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

Event Date 11/28/2019

Event Type  malfunction  

Manufacturer Narrative

A supplemental medwatch will be submitted after new information has been received.

Event Description

It was reported that the heart lung machine hl20 showed error s stop on the roller pump module and "er10" at the system control panel.Reference number: (b)(4).

Manufacturer Narrative

According to service order no#200301256 dated on 2019-11-29 the technician performed as follows: "we have checked and found that there is a problem with motor control pcb.We have replaced the same with new and tested and found it was working fine.The part was requested for investigation on 2020-02-20.On 2020-02-20 the ssu informed maquet cardioulmonary gmbh via mail that the part is already scrapped and no longer available for an investigation.Since the part is already scrapped by the ssu no further investigation is possible.The most probable root cause could not be determined.The reported failure "s-stop and er10" could not be confirmed.If the reported failure "s-stop and er10" occurred during patient treatment is unknown.The hl20 in question was responsible for this complaint/event.The occurence rate is below the acceptance rate, thus no remedial action required.The ocurrance 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: MCP00706195#VARIO TWIN, HL 20, 4-PUMPS
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9446156
• MDR Text Key: 199894178
• Report Number: 8010762-2019-00388
• 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: 02/20/2020

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?: Yes
• Device Operator: Health Professional
• Device Model Number: 701043267 - HL 20
• Device Catalogue Number: 701043267
• Initial Date Manufacturer Received: 11/28/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 02/20/2020
• Supplement Dates FDA Received: 02/20/2020
• Patient Sequence Number: 1