MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-PLS 2050#PLS SET INCL. RF 32; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BE-PLS 2050

Device Problems Unintended System Motion (1430); Device Stops Intermittently (1599)

Patient Problem No Patient Involvement (2645)

Event Date 03/27/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).

Event Description

As stated by the customer: swinging movement of the impeller inside of the centrifugal pump rf 32 has been detected during priming.The pump intermittently stopped due to no generated flow, caused by the swinging movements of the impeller inside of the centrifugal pump.The pls set (including the rf 32) has been replaced with a new pls set.No patient involvement.(b)(4).

Manufacturer Narrative

According to complaint report (dated on: 2018-03-30) the pls set has been replaced.Maquet medical systems, usa (importer) submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption#: (b)(4).Importer: (b)(4).Contact person: (b)(6).The pls set, inclusing the affected centrifugal pump (be-00987#be-zentrifugalpumpe, article number: 70101.7955) was returned to maquet for further investigation.The affected centrifugal pump has been received by maquet laboratory on 2018-07-23.According to investigation report, signed on 2018-08-23, the centrifugal pump was de-aired and connected to a rotaflow drive.Swinging movements or any noises could not be detected.The centrifugal pump is working as it should.Thus the failure could not be confirmed.Most probable root cause could be determined as improper de-airing of the centrifugal pump by the user.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

Event Description

Ref: (b)(4).

• Brand Name: BE-PLS 2050#PLS SET INCL. RF 32
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7446447
• MDR Text Key: 106850644
• Report Number: 8010762-2018-00147
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• PMA/PMN Number: K090515
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2019
• Device Model Number: BE-PLS 2050
• Device Catalogue Number: 701027818
• Device Lot Number: 70121113
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2018
• Date Manufacturer Received: 04/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1