MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLM TUBING SET W/BIOLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Pressure Problem (3012)

Patient Problems Ischemia (1942); Low Oxygen Saturation (2477)

Event Date 10/01/2019

Event Type  malfunction  

Manufacturer Narrative

A follow up medwatch will be submitted when additional information becomes available.

Event Description

Patient connected on a/v ecls procedure.With cardiohelp and hls 7050 ; after 20 mns : bad signs: the delta p was increasing, signs of desaturation of the patient, little signs of leg ischemia.They decided to change the pack hls with a new one.After less than 24 hours; same issues with the same patient.Nearly same signs, they decided to change the console with xenios one and xenios ecmo set.Since more than 24 hours , no issue was detected with xenios console.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The hls module was investigated in the laboratory on 2020-01-17.Results: during the optical inspection of the hls oxygenator, a detached silicone seal was found on the pressure sensor (connector).During the leak test according to lv 201, a leak was detected at a connecting bridge of the pump to the oxygenator.The seals have not been mounted correctly.During functional testing with the cardiohelp, no pressures were detected.The most probable root cause is that the pressure sensor got wet due to the incorrectly mounted seals.Thus the failure could be confirmed.The occurrence rate 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 cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9217478
• MDR Text Key: 200640585
• Report Number: 8010762-2019-00334
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 01/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/06/2021
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70104.7753
• Device Lot Number: 70131583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/10/2019
• Initial Date Manufacturer Received: 10/04/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 10/04/2019
• Supplement Dates FDA Received: 01/20/2020
• Patient Sequence Number: 1
• Patient Outcome(s): Other