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

Model Number BE-HMOD 30000 #SBE-QUADR.-ID PÄD.O.FILT.

Device Problem Packaging Problem (3007)

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

Event Date 07/24/2022

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

The event occurred in china.It was reported that the customer noticed that there was a small tear on the sterile bag of the quadrox-id 30000 with lotnumber 3000221560 on july 24th.It was noticed by opening the package.No damages noticed on the outer carton box.Later, a replacement oxygenator was sent to the hospital (lotnumber 3000227209), however it still showed serious crease, suspected of air leakage (this oxygenator will be handle in complaint (b)(4).The customer refused to use the product and considered it was serve quality issue on the products.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in china.It was reported that the customer noticed that there was a small tear on the sterile bag of the quadrox-id 30000 with lotnumber 3000221560 on july 24th.It was noticed by opening the package.No damages noticed on the outer carton box.A replacement oxygenator was sent to the hospital (lotnumber 3000227209), however it still showed serious crease, suspected of air leakage (this oxygenator will be handle in complaint (b)(4)).The customer refused to use the product and considered it was serve quality issue on the products.No harm to any person has been reported.The affected be-hmod 30000 #sbe-quadr.-id päd.O.Filt.Was technically investigated in the getinge laboratory on 2022-09-28.During the visual inspection two holes in the sterile bag could be confirmed.Furthermore it was detected that the outer packaging (carton box) was also damaged.An exact cause of the damage could not be determined retrospectively.The most probable cause for the reported failure "holes in sterile bag" could be determined as external force during transport which led to the damaged of the sterile barrier of the product.The production records of the affected be-hmod 30000 #sbe-quadr.-id päd.O.Filt with lot#3000221560 were reviewed on 2022-09-28.According to the final test results, all be-hmod 30000 #sbe-quadr.-id päd.O.Filt with lot#3000221560 passed the tests as per specifications.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: 15119416
• MDR Text Key: 302509357
• Report Number: 8010762-2022-00287
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K132829
• 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: 09/28/2022

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: 02/10/2023
• Device Model Number: BE-HMOD 30000 #SBE-QUADR.-ID PÄD.O.FILT.
• Device Catalogue Number: 701070396
• Device Lot Number: 3000221560
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/25/2022
• Initial Date FDA Received: 07/28/2022
• Supplement Dates Manufacturer Received: 09/28/2022
• Supplement Dates FDA Received: 09/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/10/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1