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

Model Number BE HLS 7050

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Code Available (3191)

Event Date 01/03/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the customer: patient was placed onto venous ecmo post cardiopulmonary bypass.25 fr biomedicus femoral access cannula and 23 fr biomedicus femoral return cannula were used.Ecmo commenced without incident and was running well at around 4.5l/min with normal pressures on the cardiohelp.After around 10 mins of ecmo a full dose of protamine was given to the patient without the perfusionist being aware.Around 10mins later the post oxy pressure (part) started reading minus 500mmhg giving a tmp of over 500 with loss of flows to around 1.5l/min.The access pressure was normal and consistent with a drop in flows and the pre oxy pressure (pint) was normal and consistent with flows.At this point the ecmo was clamped off and thought of re zeroing the pressure to air but then decided not to.Clamps were then removed and was unable to achieve any blood flow at all.After around five minutes clamps.(b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of the manufacturer.On the blood outlet side no clots were detected.The oxygenator was cleaned with sodium hypochlorite solution.The hls module was connected to the cardiohelp device and the pressure values shows no abnormalities.No other abnormalities were detected.Thus the reported failure could not be confirmed.The cause of this failure was determined to not be attributed to a device related malfunction.Since the reported failure did not contribute to a death or serious injury 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.

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
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 7268990
• MDR Text Key: 100265992
• Report Number: 8010762-2018-00054
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE HLS 7050
• Device Catalogue Number: 701047753
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2018
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1