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

Model Number BE-HLS 7050

Device Problem Manufacturing, Packaging or Shipping Problem (2975)

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

Event Date 03/19/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

It was reported that during an emergency, the customer opens one of the hls circuits arrived and finds a pls set inside it.No harm was reported.Complaint id: (b)(4).

Manufacturer Narrative

The following complaint information was provided to maquet cardiopulmonary: "during an emergency, the customer opens one of the hls circuits arrived and finds a pls set inside it".The customer was able to use the pls set for the patient as a rotaflow device was available.No patient harm was reported.The pls set and the carton outer box was disposed off by the hospital as the patient was infected with covid.Thus the product is not available for investigation.The customer provided pictures of the pls set label of tyvek cover and the hls set label of carton outer box.As the product was not available for technical investigation a laboratory investigation was not possible.However, the customer provided pictures of the product labels (outer box and inner box).The ssu (sales and service unit) italy was contacted for detailed shipment information of the reported hls set and pls set lot's.It was confirmed by the ssu that the customer did not receive any piece of the reported pls set lot.The hls sets have been shipped to the customer by the ssu on 2022-02-17 (one piece) and 2022-03-07 (one piece).A device history record review was performed with the following outcome: dhr review hls set batch #3000212852: the production records of the affected hls set (batch # 3000212852) were reviewed on 2022-04-04.The hls set lot 3000212852 manufacturing was finished on 2022-01-13, left the facility for sterilization 2022-01-14 and was inbounded at 3pl on 2022-02-01.The release for distribution started on 2022-02-17.Following steps are performed with a 100 % inspection: - control of order data; - 4-eye inspection of packaging and labels.According to the final test results, all hls sets with the batch 3000212852 passed the tests as per specifications.Dhr review pls set batch #3000196214: the production records of the affected hls set (batch # 3000212852) were reviewed on 2022-04-04.The pls set lot 3000196214 respectively manufacturing was finished on 2021-11-22, left the facility for sterilization 2021-11-24 and was inbounded at 3pl on 2021-12-07.The release for distribution started on 2021-12-27.Following steps are performed with a 100 % inspection: - control of order data according to the final test results, all pls sets with the batch 3000196214 passed the tests as per specifications.Based on this the reported failure "pls set within hls set carton outer box" could be confirmed.Based on the information available at this time determination of an exact root cause was not possible.As a immediate action getinge initiated a shipping hold of one be-hls 7050 #shls set advanced 7.0 which still was available at the ssu france on 2022-04-05.The ssu france put the unit on hold and the non-conformity reported on this quality hold was not applicable to this unit.The picture of the inner and outer labels were showing the same product.A review of received complaints (2 previous years) found no related records.The reported event was determined to be a single event.In order to determine the root cause and address corrective actions for the reported event getinge initiated a capa process.Additionally a health hazard evaluation was initiated.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: HLS SET ADVANCED
• 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: 13936700
• MDR Text Key: 288087453
• Report Number: 8010762-2022-00102
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/29/2022

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: 12/21/2022
• Device Model Number: BE-HLS 7050
• Device Catalogue Number: 701069073
• Device Lot Number: 3000212852
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 03/21/2022
• Initial Date FDA Received: 03/29/2022
• Supplement Dates Manufacturer Received: 05/04/2022
• Supplement Dates FDA Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/21/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose