MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH OXYGENATOR; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported from a customer from the us that customer using the hmod 70000 oxygenator and during a ecls case the arterial line came off the arterial end of the quadrox.They managed to get the livanova tubing line back on the quadrox and they continued support for the patient.The tubing was zipped tied on to the quadrox.No indication of actual or potential for harm or death reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the tubing was disconnecting from the quadrox-id arterial outlet after 24 hours of initiation va emco.The tubing set was manufactured and distributed by livanova.The oxygenator and tubing from the customer was not available for return, thus no technical investigation was possible.A medical review was already performed for a similar issue (refer complaint# (b)(4)) by getinge medical experts on 2021-02-09 with following results: ¿most probably the applied cable tie tension by the cable tie gun at the connector 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 softline and bioline instruction for use (instructions 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 softline coating [or bioline coatings] and coatings from other manufacturers are unheard of, but cannot be ruled out.Therefore, devices coated with softline 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 2021-04-14.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences can be excluded.In accordance with the quadrox-id risk analysis following probable root causes were determined: lack of attention on device handling, inappropriate fixation.Based on the investigation results no product related malfunction could be confirmed 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.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 id: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11200538
• MDR Text Key: 227786572
• Report Number: 8010762-2021-00017
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K101153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• 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: 01/20/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/04/2020
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 70124600
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/22/2021
• Patient Sequence Number: 1
• Patient Age: 58 YR