MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEART LUNG MACHINE; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/24/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.The affected hls set is requested for further investigation in the getinge laboratory but not received yet.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in (b)(6).It was reported that on the hls module blood loss from the gas outlet was detected.The customer replaced the hls set during the treatment with no injury to the patient.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in italy.It was reported that on the hls module blood loss from the gas outlet was detected.The customer replaced the hls set during the treatment.The affected hls set was investigated in the getinge laboratory on 2021-04-26.During the tightness test the leakage on the gas outlet could be confirmed.The most probable root causes could be determined as: - insufficient pur (polyurethane) grouting of the mat package.- fiber detachment in pur grouting.- fiber damage.The device history record (dhr) review was performed on 2021-04-26 and there were no references found, which are indicating a non-conformance of the product in question.Following tests were performed on the hls module: - pressure test heat exchanger.- leak test water/gas side.- pressure test blood side.- final functional test.According to the final test results, all hls modules passed the tests as per specifications.Production related influences can be excluded.Based on these investigation results the reported failure could be confirmed.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is 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.

Event Description

Complaint id: (b)(4).

• Brand Name: HEART LUNG MACHINE
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11434299
• MDR Text Key: 242778925
• Report Number: 8010762-2021-00141
• Device Sequence Number: 1
• Product Code: KFM
• 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,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 04/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2022
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Device Lot Number: 70139666
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Date Manufacturer Received: 04/15/2021
• Patient Sequence Number: 1