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 Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis (2100)

Event Date 07/05/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).(b)(6).The product was requested for return to the manufacturer for laboratory investigation but was not received yet.The investigation is still pending.

Event Description

According to the hospital: the set was put in place on (b)(6) 2018 at 3.00 pm.Flow: 3,4 l.The patient had a thoracoscopy, so the medical staff stopped the heparin between 7.00pm and 10.00pm.At 00.30 (on (b)(6) 2018), a thrombosis of the membrane was noticed.The set was replaced.No clinical consequences were reported following the event.(b)(4).

Manufacturer Narrative

(b)(4) (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: (b)(4).Contact person: (b)(4).The product was requested for return to the manufacturer for laboratory investigation.A be-hls 5050 # hls set advanced 5.0 with clots was delivered.The oxygenator was rinsed with water with sodium hypochlorite.An optical examination was performed and the oxy was connected to the cardiohelp to simulate a flow test (water cycle).Optical examination of the oxy revealed clotting on the blood outlet side.When rinsing with water, smaller clotting particles were rinsed out on the outlet side.The hls had to be cleaned twice with sodium hypochlorite.It is not feasible to simulate an application test like in the clinic, since we do not work with blood but only with water or priming solution.With the help of the cardiohelp, a water cycle was created to simulate a flow test that was in order.The sawing of the product is currently not allowed for security reasons and will be postponed to a later, unknown date.The product is archived for further investigations in our warehouse.Thus the failure could be confirmed.The probable root cause could not be determine at this time due to work safety issues in the complaint laboratory.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: 7720654
• MDR Text Key: 115364929
• Report Number: 8010762-2018-00236
• 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: 09/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/18/2019
• Device Model Number: BE-HLS 5050#HLS SET
• Device Catalogue Number: 701048127
• Device Lot Number: 70118422
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 07/17/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention