MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Pumping Problem (3016)

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

Event Date 10/11/2019

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 a hls set started to be used around 15:00 on (b)(6), 2019.The pump stopped around 6 o'clock on (b)(6) 2019.(intervention of bubble sensor intervention) then reset the bubble sensor and restart the pump.After about 20 minutes, the rotation speed increases but the flow rate does not flow, and the ecmo device is replaced.Customer doesn´t know if there was a problem with the operation of the cardiohelp-i or hls set.Information to the incident are requested but still pending (harm to the patient, bubbles visual detected, clots detected).No harm to the patient reported also no clots or bubble visual detected.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The complaint (b)(4) was reopen due to the start of the investigation.The returned product was investigated in the laboratory of the manufacturer on 2020-01-23.A visual investigation was performed and no recognizable defects were found on the product.In the leak test according to lv 201 with water, a leak was found on the pressure sensor, which is located on the blood inlet connector.The leakage at the pressure sensor could lead to the problems described by the customer (air gets into the oxy at the leakage, the pressure sensor could have got wet due to the leakage and may not have worked properly).When checking the functionality of the sensors using a cardiohelp, in our laboratory, no malfunction was found.The most probable root cause for the reported failure "pump stop (intervention of bubble sensor)" could be the detected leakage at the pressure sensor which could lead to the problems described by the customer.(air could enter the oxygenator).The reported failure "pump stop/no flow" was occurred during treatment and could be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.The ocurrance rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The sample has been received on 2019-12-10 for further investigation at maquet laboratory.The declaration of infection risk (doir) was not sent.Despite several requests the doir has not been received yet.The sample cannot be investigated.Thus the failure could not be confirmed.A review for similar complaints to be investigated already was performed and no similar complaints were found.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9215562
• MDR Text Key: 200640482
• Report Number: 8010762-2019-00333
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup
• Report Date: 02/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/14/2021
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: 70129829
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Date Manufacturer Received: 01/27/2020
• Patient Sequence Number: 1