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

Model Number BE-HLS 7050#HLS SET

Device Problem Pressure Problem (3012)

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

Event Date 12/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

Incident occurred in a clinical trial.* event type: exchange of hls-set advanced.Event description: immediately after the start of ecmo, the delta p value rose suddenly and remained between 60 and 70.As the cause of the rise in pressure was unknown, doctor suspected a malfunction of the equipment and decided to exchange hls sets (the use period of the defective equipment was within one day.).According to the doctor, health damage accompanying this event did not occur.Patient condition.Patient was weaned off the 1st ecmo on (b)(6) 2018.(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 # e2018002.Importer: maquet medical systems usa.45 barbour pond drive wayne, nj 07470.Contact person: (b)(4).The product was requested for return to the manufacturer for laboratory investigation.An hls module 7.0 advanced has been returned.The sample was contaminated.The venting membrane was wet.Clots cannot be confirmed.Sample was cleaned with sodium hypochlorite.Leak test according lv 201 was performed.A leak in the tubing connection of the blood inlet connector could be detected.(no evidence was provided that this failure was noticed within the initial complaint report.) the pump cover has been removed.The fleece cover of the internal sensor on the blood inlet cover has come off and shows a slight discoloration (possibly due to moisture).Behind the soldered contacts a crimped fiber was detected.Thus the failure could be confirmed.The most probable root cause could be that the priming solution dripped out of the un-tight venting membrane and flowed under the pump cover and hit the sensor.The sensor shows no leakage.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.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.

Event Description

Internal reference: (b)(4).

• 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: 8267228
• MDR Text Key: 134197761
• Report Number: 8010762-2019-00018
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/07/2019
• Device Model Number: BE-HLS 7050#HLS SET
• Device Catalogue Number: 701047753
• Device Lot Number: 70120208
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention