MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH MCP00703309#RPM 20-320 SINGLE ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS

Model Number HL 20

Device Problem Pumping Problem (3016)

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

Event Date 11/22/2019

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 interrupted blood flow during use.(b)(4).

Manufacturer Narrative

Information about actions performed by technician was provided on 2020-03-03: the service technician performed functional tests.Heavy cleaning and restoration of the assembled parts of chemical and biological material.Performed preventive maintenance procedure.After that, the equipment was released for clinical use.The reported failure "interrupted blood flow during use" was not reproducible.The reported failure "interrupted blood flow during use" could not be confirmed.The technician needed to heavy clean and restore the assembled parts of chemical and biological material.Therefore according to the risk analysis (dms#(b)(4) risk id: h1.1.1.4.8 the most probable root cause could be incorrect service/maintenance or insufficient user/service information/knowledge which could result in dirty assembled parts of the device which were not maintained properly.The reported failure "hl20 interrupted blood flow during use" could not be confirmed.The reported failure "hl20 interrupted blood flow during use" happend durin patient treatment.The hl20 in question was responsible for this complaint/event.The occurrence rate is below the acceptance rate thus no remedial action required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Reference number: (b)(4).

• Brand Name: MCP00703309#RPM 20-320 SINGLE ROLLER PUMP
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9446149
• MDR Text Key: 193629868
• Report Number: 8010762-2019-00386
• 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: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

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: HL 20
• Device Catalogue Number: 701027652
• Initial Date Manufacturer Received: 11/22/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 03/03/2020
• Supplement Dates FDA Received: 03/05/2020
• Patient Sequence Number: 1