MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET

Device Problem Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 commenced on ecls therapy following anaphylatic shock.Hemocrit at commencement of therapy noted by clinicians to be high.Pven pressure noted on cardiohelp-i also to be high.Fluid challenge of 1litre of hartmanns solution given.Delta pressures increasing, along with pven and hematocrit.Decision made to cease ecls via hls/ cardiohelp and switch to pls/ rotaflow circuit with clinicians concluding that microembolism of oxygenator of hls circuit.Post commencement of ecls via rotaflow/ pls circuit, patient required additional fluid loading of 3 litres.Customer complaint of faulty oxygenator.No harm to the patient was reported.Internal reference: (b)(4).

Manufacturer Narrative

The product was requested for return to the manufacturer for laboratory investigation.Maquet cardiopulmonary received the product for investigation.An hls module advanced 7.0 has been returned.As the sample was in the clinic rinsed out.No clots are visible on the lead inlet and blood outlet side.Oxygenator cleaned with sodium hypochlorite.Module to the cardiohelp connected.The values remain constant.Protective cover of the pump removed.The sensors and solder joints do not show any corrosion.No further abnormalities noted.Conclusion: failure cannot be confirmed.All values remain constant.The sensors and solder joints show no corrosion.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.Thus the failure could not be confirmed.A supplemental medwatch will be submitted after new information has been received.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 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.

Event Description

Internal reference: (b)(4).

• Brand Name: TUBING, PUMP, CARDIOPULMONARY BYPASS
• 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: 7264967
• MDR Text Key: 100131346
• Report Number: 8010762-2018-00052
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: AS
• 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: 02/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET
• Device Catalogue Number: 701047753
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/23/2018
• 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