MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0 WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problem Increase in Pressure (1491)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/21/2019

Event Type  malfunction  

Event Description

It was stated the customer put a patient on cardiohelp and soon after the delta p went to 100.They changed out the circuit for another hls set and are continuing support without the same issue occurring.(b)(4).

Event Description

Internal ref.# (b)(4), onesupport: (b)(4).

Manufacturer Narrative

Complaint / failure description: the customer stated they put a patient on cardiohelp and soon after the delta p went to 100.They changed out the circuit for another hls set and are continuing support without the same issue occurring.Further information received on 2020-01-10: oxy did seem to prime slower than normal, otherwise nothing abnormal.Investigation results: maquet gmbh requested the product in question for further investigation in the laboratory of the manufacturer on 2019-12-27.The returned product was received by the manufacture on 2020-01-15.The sample was investigated in the laboratory of the manufacturer on 2020-02-06.During rinsing of the hls oxygenator with water small clots were flushed out.The visual inspection and the tightness test according to lv 201 did not reveal any defect or leakage.During the function test of the oxygenator, with the help of the cardiohelp, no defects (pressure abnormalities, pump issues, sensor issues) could be detected.Thus the reported failure could not be confirmed.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the incident.The most probable root cause could not be determined.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9579303
• MDR Text Key: 178010348
• Report Number: 8010762-2020-00010
• 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: 02/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/11/2020
• 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: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/15/2020
• Date Manufacturer Received: 02/07/2020
• Patient Sequence Number: 1