MAUDE Adverse Event Report: NURSEL BOELENS TUBING SET OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET

Device Problem Incorrect Measurement (1383)

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

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is still pending.

Event Description

The system was implanted on friday, (b)(6) 2020, and from the start there was the problem that the internal pressure was not displayed and instead only a dashed line could be seen in the display. As a result, the deltap display was also missing. All measures to remedy the problem did not lead to success. The connector of the pressure sensor has been disconnected from the console and the disposable product. The system was shut down and restarted. The internal pressure was not displayed. The patient was at risk. The remaining pressures were zeroed several times to the atmosphere, and did not appear to be valid. The complete system was changed on (b)(6) 2020. Since then everything has worked perfectly. A defect in the console can be ruled out. The set is no longer available; it has already been discarded complaint id: (b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• 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: 11055148
• MDR Text Key: 223425573
• Report Number: 8010762-2020-00448
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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,Followup,Followup
• Report Date: 02/23/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 12/22/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: HLS SET
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70140720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: No Information
• Date Manufacturer Received: 02/08/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial