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

Model Number HMO 51000 #SQUADROX-I SMALL ADULT + FILT

Device Problem Inaccurate Delivery (2339)

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

Event Date 04/19/2022

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 during patient treatment the co2 removal of a hmo 51000 #squadrox-i small adult + filt.Was low.The oxygenation was in range, no clots were noted and the pressure has not changed.Due to co2 was abnormal they switched to a terumo artificial lung during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

It was reported that during patient treatment the co2 removal of a hmo 51000 #squadrox-i small adult + filt.Was low.The oxygenation was in range, no clots were noted and the pressure has not changed.Due to co2 was abnormal they switched to a terumo artificial lung during patient treatment.No harm to any person has been reported.The affected product was technical investigated in the getinge laboratory on 2022-07-01.During the investigation no product related malfunction could be detected.The investigation of the affected product did not indicate any technical defects.The product could be flushed without any abnormalities during cleaning and all leak tests of the blood and water side met the acceptance criteria.Thus, the reported failure was not reproducible.The most probable cause could not be determined, as no technical cause of the failure could be identified.However, the following most probable causes of the reported failure "co2 removal was low" are known according to our risk assessment quadrox-i small adult/adult, quadrox-id adult: oxygen concentration lower than 80%.Blockage of blood flow (clotting - anticoagulation measures - obstruction of filter).Lack of information on pressure drop /pressure increase.Lack of information on device handling (leakage of gas).The production records of the affected hmo 51000 #squadrox-i small adult + filt.With packaging lot#3000147915 were reviewed on 2022-07-06.According to the final test results, the hmo 51000 #squadrox-i small adult + filt.With lot#3000147915 and udi#(b)(4) passed the tests as per specifications.Production related influences are unlikely.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 14203454
• MDR Text Key: 290070244
• Report Number: 8010762-2022-00128
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K150267
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2022
• 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: HMO 51000 #SQUADROX-I SMALL ADULT + FILT
• Device Catalogue Number: 701067894
• Device Lot Number: 3000147915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/01/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/02/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose