MAUDE Adverse Event Report: MAQUET MEDICAL SYSTEMS, USA QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE; OXYGENATOR, CARDIOPULMONARY BYPASS

Device Problems Device Operates Differently Than Expected (2913); Filtration Problem (2941)

Patient Problem Death (1802)

Event Date 12/17/2015

Event Type  Death  

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) requested the product for investigation but product was not available as it has been discarded by the hospital.Based on the information available the manufacturer will not be able to confirm the failure as no investigation could be performed and no further product information could be obtained.Based on that we will close complaint # (b)(4).Furthermore no device history record could be reviewed as no product information was available.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.A supplemental medwatch will be submitted when additional information becomes available.(b)(4).

Event Description

It was reported, a patient was a post-op norwood procedure.He was placed on ecmo (b)(6) 2015.During the ecmo run the circuit was doing well but patient wasn't.On day 6 of the ecmo run the oxygenator clotted aggressively, with no warning.There was a miscalculation in the heparin dose administered by the nurse the day before.She mixed an iv bag manually instead of following protocol and using a pre-mix bag.The childs act was 150 and hospital protocol is 190 to 210.During said incident, the nurse noticed the transmembrane pressures on oxygentor rising very abruptly with no warning, they immediately tried to up the pressure and decrease the flow on oxygenator but it clotted completely off and quit working.The patient arrested at this point and the physician decided to stop all life saving measures and baby passed.

Manufacturer Narrative

(b)(4).For further investigation a clinical assessment has been done by the manufacturer.Based on the received information no evidence was found which would indicate a malfunction of the device.The used tubing set was consisting of multiple components of multiple competitors and therefore in addition multiple coating systems.The inconsistent composition of coatings, ultrafiltration and the associated enlargement of the foreign surface would allow the conclusion that the anticoagulation was not fully adequate.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.

Event Description

(b)(4).Additional information received on (b)(6) 2016: we work off of order sets - the physician sets parameters for act keep act ---- seconds - the nurse titrated the heparin by (b)(6), platelet, hct.The antithrombin and antixa are reported to the physician blood flow - this patient was on (b)(6) ml/kg/min for the run weight (b)(6) kg; (b)(6) cm.Used system components: sorin 1/4" circuit, maquet ped oxygenator; terumo hct/svo2 sensor, terumo shunt sensor a roller pump was used and no better bladder was used.Chest cannulas have been used (venous 14 fr.Arterial 8 fr.) a ultrafiltration was done.Therapy (b)(4) -- set up was the blood flow was from post oxygenator to venous line pigtail.Sign for coagulation anomaly: yes patient surgery was on (b)(6) 2015 21 days prior to ecmo - he did have bleeding problems in surgery and received factor 7.At iii was measured daily levels (b)(4) when act (b)(4).Heparin was introduced on venous line pigtail.Oxy was not flushed during ecmo.No pump stop during the time of low anticoagulation.

Manufacturer Narrative

Based on a phone call from 06/02/2016 the product for complaint # (b)(4) is available for manufacturer investigation.The product was received on 05/04/2016.Package was accidentally referenced with a wrong complaint # by customer.But the included declaration of infection risk was referenced to complaint # (b)(4).After following up with the customer the received product is related to (b)(4).Investigation is still pending.As soon as additional information becomes available a supplemental medwatch will be submitted.

Event Description

(b)(4).

Manufacturer Narrative

During visual inspection no clotting on blood inlet side was found.But on blood outlet side clotting was noticed.Oxygenator was flushed with water.Thereby no clots were flushed out.Afterwards the oxygenator was cleaned with sodium hypochlorite.No leakage was detected.Product was forwarded to qa laboratory for testing the product regarding its performance and pressure drop.Investigation is still pending.As soon as additional information becomes available a supplemental medwatch will be submitted.

Event Description

(b)(4).

Manufacturer Narrative

A clinical assessment was performed by the manufacturer, based on the received information, no evidence was found to indicate a malfunction of the device.The tubing set used consists of multiple components from multiple suppliers, and therefore there are multiple coating systems involved.Particularly the inconsistent composition of coatings, and also the introduction of ultrafiltration and the associated increase in the surface area involving "foreign" coatings means that it can be concluded that measures present for anticoagulation were not fully adequate.The product was forwarded to the qa laboratory for testing its gas exchange and pressure drop performance according to lv009.All tests were passed successfully (all measurements were within specification).For further investigation a device history record was performed that found no indication of a nonconformance of the product lot in question.To conclude, the investigation results and the available information indicate that the most probable cause for the reported incident was a combination of clinical error (miscalculated heparin dose) and use of a tubing set that was a combination of different components from various manufacturers with multiple surface coatings that affected the anticoagulation properties expected of a normal system, and this resulted in the clogging of the oxygenator, leading to the death of the baby.No further investigation or action is warranted, and the complaint will be closed.This is the final report.

Event Description

(b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET MEDICAL SYSTEMS, USA; 45 barbour pond drive; wayne NJ 07470
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5408705
• MDR Text Key: 37417846
• Report Number: 8010762-2016-00060
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K100278
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/07/2016,03/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/03/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 05/04/2016
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 09/02/2016
• Event Location: Hospital
• Date Report to Manufacturer: 01/07/2016
• Date Manufacturer Received: 09/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Death
• Patient Age: 35 DA