MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem No Device Output (1435)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/28/2020

Event Type  malfunction  

Manufacturer Narrative

The reported failure was already investigated under complaint # (b)(4) with the adhesive membrane of the pven pressure sensor has come loose.The adhesive membrane of the pint pressure sensor is yellowish and looks hardened.Hls module connected to the cardiohelp.All values remain constant.The sensors became wet and as a result the sensors can lead to erroneous measurements.Thus the reported failure could be confirmed.The most probable root cause is that the sensors got wet and therefore displayed wrong pressures.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.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 cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Abnormally high pressure internal (pint).Creating a negative delta p.Further information was provided by the ssu on 2020-02-13: lot # and udi # are not available.They recognized issues with the pressure sensor during treatment and therefore switched out the hls set.No further abnormalities were noticed.On 2020-02-14 it was stated that the product is available for return.Internal ref.# (b)(4).

• Brand Name: HLS SET ADVANCED 7.0 WITH BIOLINE COATING
• 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: 9734718
• MDR Text Key: 191443376
• Report Number: 8010762-2020-00073
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2020
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/13/2020
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1