MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEAT-EXCHANGER, CARDIOPULMONARY BYPASS

Model Number 70106.3206

Device Problem Infusion or Flow Problem (2964)

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

Event Date 11/17/2020

Event Type  malfunction  

Manufacturer Narrative

A follow-up report will be submitted when additional information becomes available.

Event Description

Report from perfusionist."the cardioplegia heat exchanger primed as normal with the tap in the 'bypass' position, all pressures and flows seemed appropriate with no reason for concern.Cpb was initiated and the cardioplegia lines were flushed ready to delivery the loading dose.All appeared to prime as normal with the tap in the 'perfusion' position.The cross clamp was then applied and cardioplegia dose was commenced, it was noted that the temperature of the blood outlet line was still warm despite the heat exchanger being 100% cold, the tap was definitely in 'perfusion' position.The heat exchanger was removed from the circuit and changed for a new plegiox with no problems.On closer inspection after the case there appears to be a problem with the blood flow pathway in the original heat exchanger.I've attached a picture of a normal plegiox with blood going all the way to the top, and the problematic plegiox were the blood seems to stop before reaching the top.I'm guessing there is a slight manufacturing defect that was preventing normal blood flow through the heat exchanger and the blood was only flowing through the bypass section of the heat exchanger.On the device there appears to be some signs of a moulding problem at the top.".

Manufacturer Narrative

Hqv 97900 was directly involved in the incident which occurred during use.It was reported that the plegiox, heat exchanger, in the tubing set not functioning as intended and temperature of the blood outlet line could not be cold and also according to customer there is a slight manufacturing defect that was preventing normal blood flow through the heat exchanger and the blood was only flowing through the bypass section of the heat exchanger.The product has been received back for investigation visual inspection of the product for damage was performed.Product was rinsed according to local procedure lv205.In order to determine of the pressure drop on the water side and on the blood side test according to local procedure lv 006 was conducted by using water as a medium at room temperature.Because of the severe contamination, the cleaning took several days.The visual inspection of the product did not reveal any damage.It could only be determined that individual fiber composites do not run in a straight line.The product was then primed with water.A comparison sample was used for priming, and no differences could be recognized.Finally, a test for measuring the pressure drop on the water and blood side was carried out based on lv 006 at room temperature.The position of the white lever was in the bypass position.The same test was later repeated on the blood side at 250 ml / min, but with the difference that the white lever was turned from bypass to perfusion position during the test.The blood inlet pressure increased from approximately 100 mbar to over 700 mbar and the flow almost came to a standstill with the same pump output of the hose pump.The pressure at the blood outlet remained almost constant.This means that the plegiox complaint sample blocks almost completely when it is placed in the perfusion position.For comparison, an intact sample was obtained and the lever was also moved from the bypass position to the perfusion position at 250 ml / min.In this comparison sample, the flow remained approximately the same and the blood inlet pressure only increased by approximately 5 mbar from approximately 95 mbar to 100 mbar.The external visual inspection of the product was inconspicuous.The results of the pressure drop test were just as inconspicuous, with the bypass valve in the "hot-shot" position.The maximum value on the blood side was 47mmhg, which means that the results of the complaint investigation met the specification of the product master's acceptance criterion (dms # 1501730-v10).Only the fiber bundles not running in a straight line were noticeable in the ¿first¿ scope of the investigation.In a subsequent flow test in the perfusion position, it could ultimately be determined that there was a sharp rise in pressure within the complaint pattern (after the bypass valve was switched from the "hot-shot" position to the perfusion position).This indicates a defect in the product within the temperature-controlled cardioplegia circuit.Possibly, there was a deviation from the production specification in the case of pur (polyurethane / plastic potting compound) potting or the mat package, which is why the malfunction occurred.Based on this the most probable cause of the failure could be determined as a production failure - faulty potting or a faulty mat package of plegiox.The failure could be confirmed.Trend search was performed and the occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.Device history record for lot 92288365 and for lot 70133002 were reviewed.There are no evidences indicating non-conformance or deviations of the product in question during manufacturing and final release of this specific lot.The reported failure is also identified current risk management file dms #1998250 v15 chapters r6.1.1, h2.4.13, h2.4.18, h2.5.13, h2.9.16, r6.7.4, h2.9.61.The mitigations are in place for this specific failure.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

Complaint #: (b)(4).

• Brand Name: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Type of Device: HEAT-EXCHANGER, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10883094
• MDR Text Key: 246856824
• Report Number: 8010762-2020-00395
• Device Sequence Number: 1
• Product Code: DTR
• Combination Product (y/n): N
• PMA/PMN Number: K090555
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/12/2021
• Device Model Number: 70106.3206
• Device Catalogue Number: HQV 97900
• Device Lot Number: 92288365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Initial Date Manufacturer Received: 11/17/2020
• Initial Date FDA Received: 11/23/2020
• Supplement Dates Manufacturer Received: 01/29/2021
• Supplement Dates FDA Received: 02/01/2021
• Patient Sequence Number: 1