MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH 01971110 #SQUADROX-I + FILTEREINHEIT; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number QUADROX-I SMALL ADULT/ADULT

Device Problems Break (1069); Leak/Splash (1354); Mechanical Problem (1384)

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

Event Date 12/11/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Report from perfusionist: as discussed with you earlier, i have attached photos of the oxygenator showing the problem i experienced whilst i was dismantling the circuit post bypass.As i lifted the oxygenator from its holder to dispose of i noticed blood/fluid escaping onto the floor.On careful inspection it was discovered that the tap on the filtered portion of the unit and its barrel had become detached from its housing causing its contents to spill out.I have retained the unit and washed it through and bagged it for your collection and its return for testing/inspection.This is a very worrying event, especially as it appears that very little force (if any) was involved to cause it to happen and would therefore like it inspected and reported on as soon as possible please.Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the tap on the filtered portion of the unit and its barrel had become detached from its housing causing its contents to spill out.The product was investigated by getinge laboratory on 2021-03-09 with the following results:.Visual inspection of the de-airing valve and the valve seat showed that the valve was not pushed in far enough.Therefore the valve was identified as defective.Incorrect installation should have been determined within the 100% process controls according to bop.The possible root causes were defined as follows; - incorrect installation of the de-airing valve - ipc (in-process control) according to bop 100% control) not effective the device history record for lot #70131999 was reviewed on 2021-03-11.Following tests are performed according to the bop as a 100 % inspection: ¿gluing connectors ¿pressure test water and blood side ¿tightness test gas and water side ¿final product test according to the final test results, the oxygenator with the serial# 1475767 passed the tests as per specifications.Based on the evaluation above the reported failure could be confirmed.The capa #472167 has been initiated on 2021-05-21 in order to investigate this issue further and to implement corrective and preventive actions.All further actions will be followed by this capa.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).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the tap on the filtered portion of the unit and its barrel had become detached from its housing causing its contents to spill out.The product was investigated by getinge laboratory on 2021-03-09 with the following results:.Visual inspection of the de-airing valve and the valve seat showed that the valve was not pushed in far enough.Therefore the valve was identified as defective.Incorrect installation should have been determined within the 100% process controls according to bop (basic operation procedure).The possible root causes were defined as follows; - incorrect installation of the de-airing valve; - ipc (in-process control) according to bop 100% control not effective.The device history record for lot #70131999 was reviewed on 2021-03-11.Following tests are performed according to the bop as a 100 % inspection: ¿gluing connectors; ¿pressure test water and blood side; ¿tightness test gas and water side; ¿final product test.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Based on the evaluation above the reported failure could be confirmed.The capa #472167 has been initiated on 2021-05-21 in order to investigate this issue further and to implement corrective and preventive actions.This capa was canceled during crb (capa review board) 2021-06-18 and the issue will be handled by an internal procedure non-conformity(nc) #3025699 red venting tap incorrectly seated.In scope of initial investigation the remaining 7 devices from the same oxygenator lot number were requested back from stock at xpo (warehouse).The conducted investigation by getinge, confirmed that the products do not show the same issues as reported in the complaint.This case is an isolated event for the reviewed time period (2020-12-15 - 2019-12-15).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.

• Brand Name: 01971110 #SQUADROX-I + FILTEREINHEIT
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11075579
• MDR Text Key: 224537886
• Report Number: 8010762-2020-00458
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup,Followup
• Report Date: 07/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/28/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/28/2021
• Device Model Number: QUADROX-I SMALL ADULT/ADULT
• Device Catalogue Number: 70102.1593
• Device Lot Number: 92271369
• Date Manufacturer Received: 06/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1