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

Model Number BEQ-HLS 7050 CA

Device Problem Device Sensing Problem (2917)

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

Event Date 01/21/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that the pressure drop of the quadrox-id has steadily increased during patient treatment.The clinicians believe that in the oxygenator was build thrombosis.The affected oxygenator was exchanged during patient treatment.This was the second oxygenator replacement during patient treatment.The first exchange is handled with in (b)(4).No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary: ¿pt placed on ecls and t arterial would not reliably display and alarmed.Worked for a while with manipulation, but then went completely away and no longer works.They did not report broken pins in sensor port but i have requested a picture.Replacing sensor cable did not work.They ultimately switched thapp to co2 removal which does not monitor arterial temperature to silence the alarm.The hls was used uneventfully until the end of the run in eccor thapp, and was discarded.¿ the affected product was discarded by the customer and therefore not available for technical investigation of the manufacturer.Thus the exact root cause of the reported event remains unknown.However, according to our risk management file the reported failure could be associated with the following: -flexible circuit board damaged, no data.Based on this the reported failure "no arterial temperature" could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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

(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): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16239817
• MDR Text Key: 308160954
• Report Number: 8010762-2023-00044
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 CA
• Device Catalogue Number: 701069065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 02/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1