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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED; OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/14/2021
Event Type  malfunction  
Manufacturer Narrative
The investigation is ongoing.A follow up medwatch will be submitted when additional information becomes available.
 
Event Description
Customer received two hls kit that both had a puncture in the internal top cover.No damage to the outer box.No patient involved.(b)(4).
 
Event Description
Complaint id # (b)(4).
 
Manufacturer Narrative
It was reported that the customer received hls set with punctured packaging.No harm to any person reported.The affected product was technically investigated at the getinge laboratory of the manufacturer on 2021-01-27.Hereby a hole was detected within tyvek cover of the hls intellipack 1.The sealing of the tyvek cover was still intact.After opening of the intellipack, it could be seen that the velcro straps (used for fixating hls module) were a bit loose.At the bottom of the intellipack one velcostrap was not fixated with adhesive tape which allows the velcostrap to slip and this led to a less fixated hls module.The weld points of the welded inlay of the intellipack 1 were still intact.The most probable cause of the reported failure "punctured packaging" was determined to be an inadequate fixation of the hls module onto the insert of the intellipack due to a missing adhesive tape.This led to vertical movement of the hls module during transport whereby the brackets of the venous measurement cell holder at the blood inlet connector pierced the sterile tyvek cover of the intellipack 1.Thus the reported failure "punctured hls set cover" could be confirmed.As a preventive action mcp production was informed about the investigation results and a retraining of the affected process was performed.The production records of the affected hls set (batch 3000179556 ) were reviewed on 2022-02-10.Following steps are performed according to the bop with a 100 % inspection: -welding of inlay with intellipack 1; -adding cohesive tape; -final check.According to the final test results, the hls module with serial number (b)(6) 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.
 
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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 Key12686638
MDR Text Key278080922
Report Number8010762-2021-00566
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K112360
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Consumer,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 02/10/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/23/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/29/2022
Device Model NumberBEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
Device Catalogue Number701052794
Device Lot Number3000179556
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/27/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/29/2021
Is the Device Single Use? Yes
Type of Device Usage Initial
Patient Sequence Number1
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