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

Model Number ROTAFLOW ENGLISH/US US-PLUG ICU

Device Problem Premature Discharge of Battery (1057)

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

Event Date 08/31/2021

Event Type  malfunction  

Event Description

It was reported that the battery runtime of the rotaflow is less than an hour.The failure occurred during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The initial failure description was that the rotaflow "battery has failed.".The reported failure occurred during patient treatment.No harm tp any person has been reported.A getinge service technician was on site on (b)(6) 2021 to repair the affected rotaflow serial#(b)(4).The technician confirmed the reported failure and the batterypack ni-cd 24v 132wh (material#701017188) has been replaced.After the replacement the device is working as intended and back in clinical use.The root cause could be determined as overdue battery replacement.Based on the investigation results the reported failure "battery failed" could be confirmed.The product in question was produced in 2015-04-01.The review of the non-conformities has been performed on (b)(6) 2021 for the period of (b)(6) 2015 to (b)(6) 2021.It does not show any non-conformity in regard to the reported product and failure.There is no indication on manufacturing issues occurred during this time, thus production related influences are unlikely.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.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.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.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.

• 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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 12982747
• MDR Text Key: 282097974
• Report Number: 8010762-2021-00654
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991864
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/13/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: ROTAFLOW ENGLISH/US US-PLUG ICU
• Device Catalogue Number: 701051712
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/31/2021
• Initial Date FDA Received: 12/13/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1