MAUDE Adverse Event Report: MAQUET GETINGE GROUP /MAQUET CARDIOPULMONARY GMBH CARDIOHELP DISPOSABLE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BEQ-HLS 7050 USA

Device Problem No Flow (2991)

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

Event Date 05/19/2022

Event Type  malfunction  

Event Description

Upon setting up the cardiohelp disposables, initially forward flow was achieved during the priming process, when forward flow stopped, but rpm continued.Disposable failure came up on the device.Multiple attempts at receipting the centrifugal pump into the head still resulted in no forward flow.The device was rebooted and the same error presented itself.The centrifugal pump was taken out of pump head and placed in hand crank.Forward flow was not achieved.This was still in the priming process.Decision was made to prime a new circuit and was successfully primed.Fda safety report id # (b)(4).

• Brand Name: CARDIOHELP DISPOSABLE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET GETINGE GROUP /MAQUET CARDIOPULMONARY GMBH
• MDR Report Key: 14513328
• MDR Text Key: 293004441
• Report Number: MW5109916
• Device Sequence Number: 1
• Product Code: KFM
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/26/2022
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701069078
• Device Lot Number: 3000207510
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2022
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR
• Patient Sex: Male
• Patient Ethnicity: Non Hispanic