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

Model Number BEQ-HLS 7050 USA

Device Problem Packaging Problem (3007)

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

Event Date 07/22/2022

Event Type  malfunction  

Event Description

It was reported that the customer received a product with puncture in tyvek cover of hls set.Product was not used.No harm was reported.Complaint id: (b)(4).

Manufacturer Narrative

The investigation of the manufacturer is ongoing.

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

The reported event occurred in usa.The following complaint information was provided to maquet cardiopulmonary: ¿puncture in tyvek lid.Product was not used and customer expects a replacement.¿ the affected product was investigated at the laboratory of the manufacturer.Hereby a hole within the tyvek cover of the hls intellipack of was confirmed.Additionally damages were detected at the protective carton over the intellipack.No other damages were detected.After opening the intellipack it was detected that the velcrostraps needed for fixating the hls module within the inlay were a bit loose.The cause of the reported failure "hole in tyvek lid" was determined to be loose velcrostraps causing enough freedom of movement of the hls module to made it possible to pierce through the tyvek cover of the hls intellipack during transport.Thus the reported failure "puncture in tyvek" was confirmed during investigation.Maquet cardiopulmonary already started a capa process in order to improve the design to prevent such packaging damage in future.The production date of the returned hls set was 2021-11-07 and the set was produced according to the bop 135 v12.The bop 135 v12 packaging specifications were identified as insufficient within capa 626941 investigations.Thus the bop 135 v12 specifications were changed via an engineering change request.The bop 135 v13 was implemented, after the production of the affected hls set, on 2022-06-21.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: 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: 15111824
• MDR Text Key: 304522406
• Report Number: 8010762-2022-00284
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/08/2022

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: 10/29/2022
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701069078
• Device Lot Number: 3000202027
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 07/22/2022
• Initial Date FDA Received: 07/27/2022
• Supplement Dates Manufacturer Received: 12/01/2022
• Supplement Dates FDA Received: 12/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/29/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1