MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050

Device Problem Device Sensing Problem (2917)

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

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Pressure sensors malfunction: as the product was discarded by the customer a laboratory investigation of the manufacturer was not possible.By the provided pictures of the cardiohelp display was determined that a warning pint sensor disconnected was displayed by the device.Part arterial pressure, pint internal pressure, delta p delta pressure and tart arterial temperature were no longer displayed displaying dashes.The production records of the affected hls module (dms# 2867242, 2861011, 2870952) were reviewed on (b)(6) 2021.Following tests are performed according to the bop as a 100 % inspection: gluing of sensors gluing of cover for temperature and pressure sensor functionality test hls module sensors and pump mounting of cover and protective caps according to the final test results, the oxygenator with serial number (b)(4) passed the tests as per specifications.Production related influences can be excluded.The customer noticed a blood leakage at / under the contact socket of the pressure sensors cable.This was also confirmed by the provided pictures.Thus the reported failure was confirmed and was most probable caused by a blood leakage nearby the contact socket which led to a pressure sensor malfunction.Based on the information available at this time and the fact that the product was not available for technical investigation it was not possible to determine an exact root cause of the reported failure "pressure sensor malfunction.Missing cap of dialysis lock and valve: as the product was discarded by the customer a laboratory investigation of the manufacturer was not possible.By the provided picture it was confirmed that the cap was missing.Thus the reported failure could be confirmed.According to the trend search this was a first of it's kind occurrence for p/n 70104.7753 with in the last 12 months; furthermore no similar complaint where a root cause was determined was found.According to the performed dhr review the cover cap was mounted and this was checked by a 100% inspection according to the bop.Thus production related influences could be excluded.The customer operated the product without the protective cap at the dialysis lock and valve.This lock and valve is tight against air entry and blood leakage, when using without the protective cap.The ifu g-360 02 of hls set advance is stating the following: missing protective caps can result in the device becoming soiled.This can lead to infections in the patient.Immediately after opening the sterile packaging, check that all connectors are protected by protective caps.Do not use the device unless all connectors are protected by protective caps.Only remove the protective caps immediately before use.Based on the information available at this time and on the investigation findings it was not possible to determine a root cause of the reported failure missing cap.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.

Event Description

By the provided pictures of the cardiohelp display it was determined that a warning pint sensor disconnected was displayed by the device.Part arterial pressure, pint internal pressure, delta p delta pressure and tart arterial temperature were no longer displayed displaying dashes.The customer noticed a blood leakage at under the contact socket of the pressure sensors cable.This occurred during patient treatment on second day.External pressure sensors were used to monitor the pressure parameters.The flow was reduced and the product was exchanged.The product was discarded by the customer due to contamination with covid-19.Also the customer reported that the cover cap of the dialysis lock and valve was missing.Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11443660
• MDR Text Key: 245130732
• Report Number: 8010762-2021-00158
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: EG
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/19/2021
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70136161
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/20/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/20/2019
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 25 YR
• Patient Weight: 100