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 Problems Material Discolored (1170); Obstruction of Flow (2423)

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

Event Date 05/31/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).(b)(6).Device requested but not yet received.

Event Description

According to the initial complaint report during patient treatment the cardiohelp i reported a failure in the flow measurement.This failure will be handle in the complaint (b)(4).But in the used hls set clotting was suspected, therefore a separate disposable complaint has been opened.Additionally it was reported personnel happens to notice that the blood in the tube system looks yellowish / white and suspects a clotting and informs the cardiotechnology.Since the system looks obviously clotted, the cardiologist disconnects the tubing.The surgery is notified and initiates an expansion of the ecls system.The application was a venoarterial ecmo with the draining cannula in the right femoral vein and the infusing cannula in the right subclavian artery.The ecmo system was explanted.Pat was anticoagulated with heparin.Anticoagulation was in the recommended therapeutic range.The device, as well as the oxygenator including tube system were secured and are currently stored on the cardiotechnology.No clinical consequence due to the event was reported.(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).Rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption #(b)(4).Importer- maquet medical systems usa (b)(4).Contact person-(b)(6).The product was requested for return to the manufacturer for laboratory investigation.An oxygenator (article number (b)(4).#hls module advanced adult) was delivered in a very heavily clotted state.The oxy was rinsed with water, disinfected and cleaned 3 times with sodium hypochlorite.Rinsing the oxy with water from the blood inlet side was not possible (rinsing tube has jumped off the connector).In the inlet connector as well as in the pump large clots have settled.When attempting to rinse from the blood outlet side, these strong clots have been rinsed out.The opening (sawing) of the oxygenator is currently not possible for safety reasons.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.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.No corrective action is needed.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: 7613617
• MDR Text Key: 112025402
• Report Number: 8010762-2018-00213
• 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: 06/19/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE HLS 7050 #HLS SET
• Device Catalogue Number: 701047753
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention