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

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 08/11/2017

Event Type  malfunction  

Manufacturer Narrative

The product was not requested to return for manufacturers laboratory investigation as the information provided by the customer leads to the following conclusion: the most probable cause of the reported failure based on the information provided by the customer for this specific hospital is that the hospital protocol does not allow cardboard boxes in surgical restricted areas (the cardboard outer box should protect the inner hls kit from damage).Therefore the hls kits are removed from box and placed on storage shelf in restricted substerile area.The tyvek top cover was torn while in storage.Another hls kit was stacked on top.The cause of this failure was determined to not be attributed to a device related malfunction.Thus the reported failure could not be confirmed.Based on the trend search performed it was also determined that this is the first of it's kind report from the specific hospital.Also no other complaint was reported to be related with storage conditions causing a damaged tyvek top cover.Mcp started a risk evaluation request ((b)(4)) for the reported issue in order to evaluate if there is a risk and implement appropriate actions if needed.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time the event has been reported with a delay due to our retrospective examination of the record.At the time (2017-08-15) the complaint was reviewed and found not to be reportable.Current day, we compared the record with equivalent events, and found an inconsistency with the reporting decisions.With the current knowledge and the current team of complaint handlers, we have come to conclude the event should have been reported.As a remedial effort, we will report it within capa # (b)(4).

Event Description

Hospital protocol does not allow cardboard boxes in surgical restricted area.Hls kits are removed from box and placed on storage shelf in restricted substerile area.The tyvek top cover was torn while in storage.Another hls kit was stacked on top.Account is requesting that we re-evaluate the strength of the tyvek material as this has occurred once before in the past.Account is requesting the hls kit be wrapped in plastic bag for extra strength.Since the sterility of hls is compromised, the account will use as training circuit.Complaint id: (b)(4).

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11221874
• MDR Text Key: 231584021
• Report Number: 8010762-2021-00034
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Device Lot Number: 70118167
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/15/2017
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: N
• Patient Sequence Number: 1