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 Pressure Problem (3012)

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

Event Date 09/28/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

I received a call from (b)(6), ccp who reported that they had a patient on an hls set and the p art went from around 110-120 mmhg down to 20 mmhg for no known reason.The p interior remained the same as well as the flow, so she believed it was a faulty pressure.She decided to change the circuit to a new hls set and the pressures were normal with the new disposable.She agreed to keep the disposable to send in for inspection.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The suspected hls module was investigated by the manufacturer.The visible inspection did not show any defects on the internal sensors or the oxygenator.A tightness test according to lv 201 and a pressure test with a connected cardiohelp was performed.No abnormalities were discovered.No root cause could be determined.Further a device history review was performed and there were no references found, which are indicating a nonconformance of the product in question.Thus the failure could not be confirmed.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action required.

• 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: 9217477
• MDR Text Key: 200640827
• Report Number: 8010762-2019-00335
• 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: 11/18/2019

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: 02/19/2021
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 70105.2794
• Device Lot Number: 70129850
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2019
• Initial Date Manufacturer Received: 09/28/2019
• Initial Date FDA Received: 10/22/2019
• Supplement Dates Manufacturer Received: 09/28/2019
• Supplement Dates FDA Received: 11/18/2019
• Patient Sequence Number: 1