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

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

Device Problem Failure to Prime (1492)

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

Event Date 04/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in canada. It was reported that the priming of the hls set was unsuccessful. When the plasmalyte-a was dropped, we were unable to prime by gravity or by increasing rpms. Both perfusionists took turns manipulating the circuit to try to get it primed but to no avail. When the rpms were increased, the console would make a loud rumbling sound, much louder and more vibrations than if the membrane were decoupled, which the perfusionists accounted for by detaching and reattaching the pump to the console as well as reducing the rpm to zero. No indication of actual or potential for harm or death has been reported. The set was not used for treatment. Due to the delay in procedure (50 second arrest time) and the device was changed within the reported event a report is required. The event will be investigated in further complaints: (b)(4), (b)(4), (b)(4). Complaint id: (b)(6).

• 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: 11759098
• MDR Text Key: 250842395
• Report Number: 8010762-2021-00279
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112360
• 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
• Report Date: 08/18/2021

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 05/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes

Device Operator

• Device Expiration Date: 02/01/2022
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 3000147588
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 08/01/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• Is the Device Single Use?: Yes

Is This a Reprocessed and Reused Single-Use Device?

• Type of Device Usage: Unkown