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

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

Device Problem Disconnection (1171)

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

Event Date 01/22/2020

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 the used livanova smart tubing disconnected from the oxygenator outlet connector during patient use.Tubing was pushed over all barbs and tye-banded per their normal routine.They have used this tubing for over 10 years and have never had tubing separate from an outlet before, with old quadrox-id adult and pediatric.The customer is questioning the specification of the newer quadrox-id adult.Customer says smart tolerance range is 0.375 to 0.378 and is asking what our tolerance range is.Lot# of the used oxygenator is unknown.Customer did not save device.This issue is already forwarded to the life cycle engineering for disposable.Response is still pending.The ssu is already asked if livanova is also informed about this incident.It is also possible that the tolerances of the tubes are not correct.Complaint id: (b)(4).

Event Description

Complaint id: 320203.

Manufacturer Narrative

The reported failure "tube disconnected from the outlet connector "occurred during use.The affected oxygenator is not available for further investigation by the manufacturer.Customer did not save the device.A review for similar complaints to be investigated already was performed and no similar complaints were found.According to the ssu dated on (b)(6)2020 the tubes were not secured with ties on the outlet connector.Thus the failure could not be confirmed.According to the life cycle engineering (lce) consumables the tolerance range on the 701067859 beq-hmod70000-usa #squadrox-id ad.O.Fil.(screw connector) has not been changed compared to the oxygenator with glue connector.All external dimensions of the connector (relevant with regard to the connection) have not been changed.(see email in the attachment) as stated in the complaint the used tubing set was from the manufacturer livanova.According to the ssu liva nova is also informed about the incident.The risk assessment quadrox-i small adult/adult, quadrox-id adult dms # 1464420 v15 chapter r6.1.1.1,r6.1.1.2, r6.1.1.3, r6.1.1.4, r6.1.1.5 and r6.1.1.6 was reviewed on 2020-06-10 with the following outcome: the most possible causes for the reported failure "tube disconnected from the inlet connector" could be determined as: * lack of attention on device handling * inappropriate fixation the reported failure "tube disconnected from the inlet connector" occurred during use and could not be confirmed.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: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10066709
• MDR Text Key: 203311174
• Report Number: 8010762-2020-00167
• 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: 06/10/2020

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: 07/12/2020
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 70123622
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/12/2020
• Initial Date FDA Received: 05/18/2020
• Supplement Dates Manufacturer Received: 06/09/2020
• Supplement Dates FDA Received: 06/10/2020
• Patient Sequence Number: 1