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

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

Device Problem Patient Device Interaction Problem (4001)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/10/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

They stated that the patient had been on for 24 hours when noise occurred on the centrifugal pump and the patients hgb level decreased.As a result they had to give multiple units and took the patient off the cardiohelp and put them on the caentrimag.No harm to the patient was reported.Complaint id: (b)(4).

Event Description

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

Manufacturer Narrative

The getinge laboratory received the sample on 2019-09-30.The investigation has been performed by the laboratory on (b)(6) 2022.In the course of the visual inspection massive clots were detected on the blood inlet side and in the pump of the hls module.After the sample was cleaned several times with sodium hypochlorite it was connected to the cardiohelp and started slowly.No noise could be detected even after increasing the flow.The reported failure occurred during treatment and could not be confirmed.The device was directly involved in the reported incident.In complaint # (b)(4) our director clin.Risk manager stated: "if through massive clotting the blood flow through the oxy is difficult, then this may possibly lead to noises.Noise is indeed possible.Since the clots were rinsed out during the examination before it was tested with the cardiohelp, the basic conditions have been changed.Of course, these sounds are not mandatory, but when the clots are removed, of course, no reproducibility is possible.As a result, it would be possible for the clot to cause abnormal noise in the pump." therefore the most probable root cause could be the detected clots in the pump.But as the clots were rinsed out before the pump was tested with the cardiohelp, no abnormal noise could be confirmed by the laboratory.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.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: 9133418
• MDR Text Key: 199893327
• Report Number: 8010762-2019-00308
• 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: 11/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2019
• 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
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/30/2019
• Date Manufacturer Received: 10/28/2019
• Patient Sequence Number: 1