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

Model Number 701027652

Device Problem Battery Problem (2885)

Patient Problem Death (1802)

Event Date 08/01/2019

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was stated that the hl20 battery has failed in emergency mode after a few (approx.5) minutes.The planned transfer of the patient had to be paused and the heart-lung machine reconnected to the socket.The patient had to be connected to an ecmo in the corridor of the cardiac catheter laboratory in order to be able to be transferred to the operating theatre.The patient past away during the treatment.This was caused due to damaged myocardium.(b)(4).

Event Description

Complaint# (b)(4).

Manufacturer Narrative

This follow up 2 report was created in order to correct the "type of reportable event".In follow up 1 report it was accidentally ticked "malfunction".However, this is a death case.

Manufacturer Narrative

A getinge field service technician was sent out to investigate the unit in question.According to the service report following was found: the field service technician investigated the hl20 unit and found that the batteries were defective.The defective batteries were replaced and functional test of batteries changeover and charge/discharge of batteries were checked.Furthermore, the unit in question ran on battery mode.The test ran was successful.Electrical safety check has been successfully performed as well.All test values are within the limit values.The unit passed all safety and electrical tests.The root cause analysis is ongoing.

Event Description

Complaint# (b)(4).

Manufacturer Narrative

The defective batteries have been requested with rma# 39714 for return on 2019-11-14.Goods received in life cycle engineering (lce) on 2019-11-22.Investigation was performed in the lce in rastatt on 2020-03-09.The outcome of the investigation was documented in lce investigation report no.#(b)(4): an optical inspection of both batteries showed no mechanical damage or other abnormalities.Both investigated batteries were deeply discharged.After a 7.5h charging to approximately 50% of the original capacity the internal resistances of the batteries were measured.The increase of the internal resistance at high load does not indicate a significant reduction in the capacity.Therefore the batteries are not the cause of the reported failure.After the investigation of lce, the field service technician (fst) visited the customer again to check if the charging module of the hl20 is working to factory specs.On 2020-04-20 the fst provided service order# (b)(4).According to the service order the hl20 charging module works fine.Medical review was received on 2020-04-28 with following conclusion: the hl20 did not have a malfunction.An application error is possible.A connection between the causes of death and the loss of therapy due to a failure cannot be confirmed nor excluded.The reported failure "battery failed in emergency mode" could not be confirmed.The reported failure "battery failed in emergency mode" occurred during patient treatment (patient died).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: RPM 20-320 SINGLE ROLLER PUMP MODULE, HL 20
• Type of Device: CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 8923476
• MDR Text Key: 155316763
• Report Number: 8010762-2019-00258
• 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,Followup,Followup
• Report Date: 05/04/2020

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: 701027652
• Device Catalogue Number: MCP00703309
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 08/01/2019
• Initial Date FDA Received: 08/22/2019
• Supplement Dates Manufacturer Received: 09/04/2019; 10/01/2019; 08/01/2019
• Supplement Dates FDA Received: 10/01/2019; 10/02/2019; 05/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death