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

Model Number ROTAFLOW CHINESE ZH-PLUG

Device Problem Device Displays Incorrect Message (2591)

Patient Problem No Information (3190)

Event Date 05/25/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from (b)(6) that bat err occurred when rotaflow console was running on battery power.Replace a new battery, same error.When the incident occurred in requested but still pending.No more details were provided.Also is it not clear which exact battery error occurred.Complaint id: (b)(4).

Manufacturer Narrative

The reported failure "battery error" occurred during use.Customer used a backup rotaflow.According to the communication grid dated on 2020-06-29 the battery pack (701017188) was replaced.Still the same error.The battery was not replaced in the last two years.Stated on 2020-07-02 the power supply board (70101.1675) is malfunctioning and will be replaced.The rotaflow risk analysis version v06 (dms# 2023689) chapter h1.1.1.21 was reviewed on 2020-07-27 with the following outcome: the most possible causes for the reported failure "battery error": 1.Defect batteries.2.Power supply board failure.3.Software error.4.User forgot recharge.5.Defect of charger unit.Further mitigation are included in the instruction for use (ifu rotaflow| 4.2 | en | 13 ) as warnings in chapter 3.3.4 battery operation: - 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.- the actual run time during battery operation depends on the age and condition of the batteries, current consumption of the rotaflow console and other factors.The run time shown is only a reference value.The actual run time can be shorter or longer.The reported failure "battery error" occurred during use and could be confirmed.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: 10119676
• MDR Text Key: 194039374
• Report Number: 8010762-2020-00190
• 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: 07/27/2020

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: ROTAFLOW CHINESE ZH-PLUG
• Device Catalogue Number: 701046405
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 05/27/2020
• Initial Date FDA Received: 06/04/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 07/27/2020
• Patient Sequence Number: 1