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

Model Number BE-HLS 5050#HLS SET

Device Problem Medical Gas Supply Problem (2985)

Patient Problems Death (1802); Patient Problem/Medical Problem (2688)

Event Date 01/27/2019

Event Type  Death  

Manufacturer Narrative

The product was requested for return to the manufacturer for laboratory investigation but was not received yet.(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

According to the customer: patient going into a vv ecmo on (b)(6) 2019.It seems that the hls membrane wasn't able to oxygenate properly, the postmembrane gasometry showed unaccustomed values (p/f 150 with fio2 1).Additional information: the device was not exchanged during use.It was used till the end of therapy.The patient finally died on (b)(6).Patient was not weaned.As far as we know the patient¿s death was not directly related to the device, his lungs were in very poor condition.(b)(4).

Event Description

Internal reference: (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- (b)(4).Contact person- (b)(4).Maquet cardiopulmonary gmbh requested the product for investigation.The returned sample was investigated in the laboratory of the manufacturer on 2019-02-13.An hls module advanced 5.0 has been returned.The sample was contaminated.Visual inspection performed.The venting membrane was bloody.No abnormalities detected.Sample cleaned with sodium hypochlorite.Water cycle created with the cardiohelp.During venting, the venting membrane leaked immediately.Vent membrane was closed.The hls module ran on the cardiohelp for several hours and showed no abnormalities.Further investigation steps are momentarily not possible to be executed due to work safety issues in the complaint laboratory.Maquet cardiopulmonary is currently in the mitigation of this issue.When further investigation steps can be executed again, these investigations will be performed and the complaint file will be updated accordingly.To ensure performance of the products prior to shipment, checks, controls, and performance tests are carried out during the manufacture of the products.These tests can be reviewed as part of a dhr review.Dhr review result: affected product: 70104.7873 be-015503112#hls mod advanced small adult basic lot 70126590 and packaging lot 70126144 (serial# (b)(4)).The avz from serial# (b)(4) to serial# (b)(4) (dms# 2675210) was reviewed on 2019-02-19.There were no references found, which are indicating a nonconformance of the product in question.Thus the failure could not be confirmed.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.Clinical assessment created by our therapy application manager: "the objectionable hls module 5.0 was to judge by the data, at its achievement limit regarding the gas exchange.According to the report, the users do not cause the death of the patient causally on the used hls set.The data now transmitted from spain supported this claim.The examination of the affected device also revealed no abnormalities.It is assumed that the purpose of the device has been fulfilled." since no device related malfunction could be confirmed and no systemic issue could be determined no corrective action is needed at this time.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.

• Brand Name: HLM TUBING SET W/BIOLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8326592
• MDR Text Key: 135776706
• Report Number: 8010762-2019-00034
• 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: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

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: 12/06/2020
• Device Model Number: BE-HLS 5050#HLS SET
• Device Catalogue Number: 701048127
• Device Lot Number: 70128879
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/30/2019
• Initial Date FDA Received: 02/11/2019
• Supplement Dates Manufacturer Received: 01/30/2019
• Supplement Dates FDA Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Death