MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID ADULT O.FILT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMOD 70000-USA #SQUADROX-ID ADULT O.FILT

Device Problem Disconnection (1171)

Patient Problems Death (1802); Insufficient Information (4580)

Event Date 12/15/2020

Event Type  Death  

Manufacturer Narrative

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

Event Description

(b)(6) year old male patient was placed on vv support via groin and neck at 1448.Flow was at 4.5l/min, rpm 3500.There were no flow issues.Circuit abruptly "ruptured" at 1518."circuit disconnected and he immediately coded" and subsequently died.This is a livanova tubing pack that they have used for years and they are very familiar with the quadrox oxygenator.(b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a tubing was disconnecting from the quadrox-id outlet.As stated by the customer the same issue occurred twice in the months before this event (reported under #406344 (8010762-2020-00453) and #406348 (8010762-2020-00454)).The tubing was manufactured and distributed by liva nova.The customer disposed the oxygenator and tubing, thus no technical investigation was possible.For further investigation the provided information was analyzed by getinge medical experts on (b)(6) 2021 with following results: ¿most probable the applied cable tie tension by the cable tie gun at the connection between the tubing and oxygenator outlet was not sufficient.This could cause a disconnection at lower pressures than expected.Another aspect could be an incompatibility of the quadrox-id in combination with the livanova tubing which may be observed in the following manners: an unexpected, yet slightly, larger inner diameter of the tubing may lead to greater possibility of tubing disconnection from the barbed connector due to decrease in surface area contact.A greater resistance, or decrease in pliability, of the tube itself due to a change in tubing shore (aka durometer).A change in tubing shore may account for a need to apply increased tension to particular tie band to assure proper fixation of the connector and the tubing junction.The maquet bioline instruction for use (bioline coating, g-063, v04, chapter 6.2 interactions with other substances) state the following with respect to the use of differing coatings: ¿interactions between bioline coatings and coatings from other manufacturers are unheard of, but cannot be ruled out.Therefore, devices coated with bioline coating must not be combined with systems featuring other coatings.Combinations of maquet coatings can be used without any problems¿.The production records of the affected quadrox-id module were reviewed on 2021-02-10.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences can be excluded.The customer confirmed on 2021-03-12 that they never put cable ties on the outlet although cable ties were provided.The customer suspected that new employees in the hospital did not put on the tubing far enough on the connector.In accordance with the quadrox-id risk analysis following most probable root causes were determined as: lack of attention on device handling; inappropriate fixation.Based on the investigation results no product related malfunction could be confirmed.There does not appear to be an association between the expiration of the patient and the reported failure.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.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.H3 other text: 4115.

• Brand Name: QUADROX-ID ADULT O.FILT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11064700
• MDR Text Key: 223378922
• Report Number: 3008355164-2020-00027
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Type of Report: Initial,Followup
• Report Date: 04/22/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/09/2022
• Device Model Number: HMOD 70000-USA #SQUADROX-ID ADULT O.FILT
• Device Catalogue Number: 701067840
• Device Lot Number: 70135559
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2021
• Distributor Facility Aware Date: 04/21/2021
• Device Age: 12 MO
• Event Location: Hospital
• Date Report to Manufacturer: 04/22/2021
• Date Manufacturer Received: 04/21/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 73 YR