MAUDE Adverse Event Report: 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 Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/18/2020

Event Type  malfunction  

Event Description

We had a patient today on vv ecls that required a circuit exchange.The patient was flowing at 3.5l at 3600 rpms with venous pressures of -50s, pint 123, part 112 delta p 11.After a patient turn flow drops to 1.6, venous drain was -5, pint was 70, part was 60 delta 10.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

As the hls set was already discarded by the customer no technical investigation could be performed.For further investigation the dhr was reviewed and did not show any abnormality or issue that is related or can have led to the customer complaint.Thus the failure could not be confirmed.According to project manager r&d a probable root cause is an impairment of the rotor due to a thrombus or mechanical damage.The occurrence rate was calculated for the reported failure 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.

• Brand Name: HLS SET ADVANCED 7.0 WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• MDR Report Key: 10081990
• MDR Text Key: 191819836
• Report Number: 8010762-2020-00172
• 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
• Type of Report: Initial,Followup
• Report Date: 07/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2020
• Is this an Adverse Event Report?: No
• 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
• Device Lot Number: 70136914
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1