MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number MCP00706045#ROTAFLOW FRENCH EU-PLUG

Device Problems Pumping Stopped (1503); No Visual Prompts/Feedback (4021)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/28/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that the rotaflow console stopped during a therapy.The rotaflow console was on battery and the alarm had rung but the "the battery operation led" had not lighted.Customer stopped the alarm.The issue was that "the battery operation led" was not lighting even if the rotaflow console was on battery.The other led "external voltage led" and "battery charging led" are ok.No indication of actual or potential for harm or death has been reported.Complaint id:(b)(4).

Manufacturer Narrative

The event occurred in france.It was reported that the rotaflow console stopped during a therapy.The rotaflow console was on battery and the alarm had rung but the "the battery operation led" had not lighted.Customer stopped the alarm.The issue was that "the battery operation led" was not lighting even if the rotaflow console was on battery.The other led "external voltage led" and "battery charging led" are ok.No indication of actual or potential for harm or death has been reported.A getinge field service technician investigated the affected rotaflow console with s/n (b)(6) and the technician was able to confirm the reported failures "pump stop/battery led not light up".The rf front panel charging status bar with article number 701034016 and additional two rubber feet with article number 701054567 has been replaced.As the battery operation led had not lighted the rfc was running on battery mode for 90 minutes.The customer was not aware that the rfc was running in the battery mode and continued the operation until the pump stopped.The root cause for the reported "pump stop" could be determined as an empty battery.The reported failure "battery led not illuminated" was already investigated by getinge life cycle engineering: general information: the display board shows the power supply of the rotaflow console with 3 leds (led1 to led3).Each led display consists of 4 single leds connected in series.The left led (green) lights up when the rotaflow console is powered by the internal transformer or by the odu connector in the base plate of a hl20 console with 24v.The middle led (yellow) lights when the rfc is powered by the internal battery.The right led (yellow) lights up when the battery is charging, together with led 1.Most probable root cause: corrosion of the printed circuit board (pcba).A device history review (dhr) was performed on 2021-06-10 and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on the investigation results the reported failure "pump stop/battery led not light up" could be confirmed, in order to avoid reoccurrence of the reported failure, the sales and service unit (ssu) will be informed to follow the chapter in the instruction for use heart-lung support system rotaflow system| 4.3 | en | v14.Chapter 3.3.4 check battery capacity every 6 months, at the latest.The battery must be replaced by the authorized technical service every 2 years, at the latest.The battery must be replaced sooner if it cannot be fully charged within 8.5 hours or if the system cannot be operated with the fully charged battery.Under normal load and with fully charged, new batteries and a flow rate of 5 lpm, the rotaflow system can be operated for at least 1.5 hours with the battery back-up.During battery operation, the rotaflow console emits an acoustic alarm or a reminder signal and corresponds to the current battery voltage on the status display.The acoustic alarm can be switched off with the "audio off" button.The reminder signal cannot be switched off.¿ chapter 5.6.1 before starting the application, check the points listed in "check before every use".Before each use, ensure that the batteries are fully charged.If the battery capacity is low an acoustic signal sounds on the device.Chapter 4.3 at the beginning of the self-test, check that all the points on the displays and all the leds are lit up, and that an acoustic alarm is emitted.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

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11965410
• MDR Text Key: 255079872
• Report Number: 8010762-2021-00342
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K991864
• 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: 08/13/2021

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: MCP00706045#ROTAFLOW FRENCH EU-PLUG
• Device Catalogue Number: 701043293
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/28/2021
• Initial Date FDA Received: 06/09/2021
• Supplement Dates Manufacturer Received: 07/23/2021
• Supplement Dates FDA Received: 08/13/2021
• Patient Sequence Number: 1