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 Problems Coagulation in Device or Device Ingredient (1096); Insufficient Flow or Under Infusion (2182)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/17/2019

Event Type  malfunction  

Event Description

It was stated that the oxygenator clotted after 8 days of vv ecmo despite being on systemic anticoagulants.Initially it was stated that there was severe hypoxemia, but it was later confirmed that no permanent patient damage occurred.The disposable was exchanged during treatment.Patient is infected by avian flu and klebsiella mdr.Internal ref.# (b)(4), onesupport: (b)(4).

Event Description

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

Manufacturer Narrative

The patient was infected with a who risk group 3 or 4 disease (avian flu and klebsiela mdr) the disposable could not be investigated.A review for similar complaints to be investigated was performed and no similar complaint were found.As stated by the customer the oxygenator clotted after 8 days of starting the operation (refer attachment).Clotting is a known phenomenon to mcp and the cause of this incident was determined to not be attributed to a device related malfunction.Based on these results and the information available at this time, the oxygenator in question operated within mcp specifications.Thus the failure could not 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 cardiopulmonary¿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: 9529196
• MDR Text Key: 199897457
• Report Number: 8010762-2019-00402
• 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?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/17/2021
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: 70132899
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/17/2019
• Initial Date FDA Received: 12/30/2019
• Supplement Dates Manufacturer Received: 12/17/2019
• Supplement Dates FDA Received: 01/21/2020
• Patient Sequence Number: 1