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

Model Number HL 20

Device Problem Pumping Problem (3016)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/06/2020

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when new information becomes available.

Event Description

It was reported that th hl20 pump showed error message: "belt slip" and error message: "safety-s." reference number: (b)(4).

Manufacturer Narrative

Device was manufactured in 2015-10-22.The review of the non-conformities during the period of 2015-10-22 to 2020-11-06 does not show any non-conformity in regard to the reported product and failure.There is no indication that manufacturing issues occurred during this time, thus production related influences can be excluded.According to the service report (attached) provided on 2020-01-11 the field service technician (fst) performed as follows: the fst replaced the tacho board and observed the unit 1 hour.No further alarm occurred.Unit handed over to customer within factory specification.The reported failure was "error message: safety-s and belt slip".Explanation of the failure: difference from the value of the optical tacho to the motor tacho is higher than 10%.According to the statement from life cycle engineering on 2019-11-11 the most probable root cause is as follows: a damaged foil or a defective tacho board is a plausible cause for the message "belt slip".Because the sensor no longer detects one or more lines on the film, it measures an apparently low speed at the pump head.Since this speed is then lower than the motor speed, the pump interprets this as a slipping belt and displays this message.The error message: "safety-s" occurs after the error message: "belt slip" was displayed because of the safety system of the hl20 console.The reported failure "error message: belt slip and safety-s" could be confirmed.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 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: 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: 10843242
• MDR Text Key: 216356668
• Report Number: 8010762-2020-00392
• 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: 01/14/2021

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: 70102.8580
• Initial Date Manufacturer Received: 01/11/2021
• Initial Date FDA Received: 11/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1