MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-HLS 7050#HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET ADVANCED

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/21/2018

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

According to the customer: on initiation of ecls support on a patient the venous pressure was seen jumping between 400 and 800 mmhg.The circuit was primed and zeroed as per guidelines and left running for an unknown amount of time before the circuit was used.Trouble shooting included the pressure sensor cable changed out with no affect.The circuit was then placed onto a second cardio help with no change in result.The decision was made to change to a new circuit.Additional information: the incident occurred during patient treatment.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary(b)(4) rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4) importer- maquet medical systems usa (b)(4) contact person- (b)(6).The defective hls module advance was sent to the manufacturer for investigation.The sample was contaminated and was cleaned several times with sodium hypochlorite.The pump's protective cover has been removed.The contacts and pcb of the venous pressure sensor are corroded.The module was connected top the cardiohelp and a water circuit was created according to the ifu.Venous pressure on the cardiohelp shows no changes or other abnormalities.Possible cause of error: after venting, the yellow cap must be replaced on the vent luer lock (see ifu).If the cap is not put back on the luer lock, the membrane gets wet after some time and drips onto the pressure sensors.When the sensors are dried, most of them work properly again.

Event Description

Ref.: (b)(4).

• Brand Name: BE-HLS 7050#HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7586594
• MDR Text Key: 111048775
• Report Number: 8010762-2018-00204
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• 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: 07/25/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2018
• Device Model Number: HLS SET ADVANCED
• Device Catalogue Number: 701046577
• Device Lot Number: 70118649
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/14/2018
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1