MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HMOD30000-USA #SQUADROX-ID PÄD.O.FIL

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

It was reported that a leakage at the gas outlet connector of the quadrox-id pediatric was noticed during patient treatment.In addition, a leakage at the housing in the area of the gas exhaust was noted.The quadrox-id was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a leakage at the gas outlet connector of the quadrox-id pediatric was noticed during patient treatment.In addition, a leakage at the housing in the area of the gas exhaust was noted.The quadrox-id was exchanged during patient treatment.No harm to any person has been reported.The affected product was technically investigated in the getinge laboratory on 2022-10-27.During visual inspection scratches could be detected on the oxygenator.A tightness test of the water side was performed and the reported failure "leakage" was reproducible.A leakage could be determined at the gas outlet connector and at the housing of the oxygenator.Further a external ct scan was required for root cause identification.The production records of the affected beq-hmod30000-usa #squadrox-id päd.O.Fil with packaging lot#3000219648 were reviewed on 2022-10-20 for the reported failure.According to the final test results, the beq-hmod30000-usa #squadrox-id päd.O.Fil with lot#3000219648 and udi#2293 passed the tests as per specifications.Production related influences are unlikely.Further investigation is ongoing.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).

Event Description

Complaint id:(b)(4).

Manufacturer Narrative

It was reported that a leakage at the gas outlet connector of the quadrox-id pediatric was noticed during patient treatment.In addition, a leakage at the housing in the area of the gas exhaust was noted.The quadrox-id was exchanged during patient treatment.No harm to any person has been reported.The affected product was technically investigated in the getinge laboratory on 2022-12-08.During visual inspection scratches could be detected on the oxygenator.A tightness test of the water side was performed and the reported failure "leakage" was reproducible.A leakage could be determined at the gas outlet connector and at the housing of the oxygenator.The exact root cause of the reported event could not be determined during investigation.The production records of the affected beq-hmod30000-usa #squadrox-id päd.O.Fil with packaging lot#3000219648 were reviewed on 2022-10-20 for the reported failure.According to the final test results, the beq-hmod30000-usa #squadrox-id päd.O.Fil with lot#3000219648 and udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely.The trend search in the complaint data base shows that this is no systemic issue.Two similar additional complaints were recorded within the last 12 months.Based on the investigation results the reported failure "blood leakage from gas outlet connector and housing" could 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.

• Brand Name: QUADROX-ID PEDIATRIC
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 15190537
• MDR Text Key: 302870471
• Report Number: 8010762-2022-00312
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 12/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/02/2023
• Device Model Number: BEQ-HMOD30000-USA #SQUADROX-ID PÄD.O.FIL
• Device Catalogue Number: 701070397
• Device Lot Number: 3000219648
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1