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U.S. Department of Health and Human Services

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

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MAQUET CARDIOPULMONARY GMBH TUBING SETS OXYGENATOR, CARDIOPULMONARY BYPASS Back to Search Results
Model Number HLS ADULT
Device Problem Packaging Problem (3007)
Patient Problem No Patient Involvement (2645)
Event Date 12/31/2019
Event Type  malfunction  
Event Description
(b)(6) reported that the tyvek cover of the hls set had a hole in it. Customer has retained the entire unit and placed in a safe storage location. The unit was not used on a patient. Issue discovered while placing the product into inventory. (b)(4).
 
Manufacturer Narrative
Three pictures were attached to the complaint. You can see that the tyvek cover is punctured. Maquet cardiopulmonary is aware of the similar complaint # (b)(4) which was investigated with the following results: before opening the tub, the tensile test (checking the seal seam strength on the transport packaging) was carried out on the welded-on tyvek cover. The result was ok. During visual inspection several damages at the outer carton box were detected. Beside of this the tyvek peel cover was forced through. It was also determined that the quadrox's inlay within the tray, which is connected to the trays inner wall by welding spots, was unsoldered. Due to this the blood outlet connector of the unsecured product within the tray was able to force through the tyvek peel cover. This was most probable caused due to excessive physical force during transport. Thus the reported failure could be confirmed. The product was directly involved with the reported incident. In regards to the packaging of several product a capa process capa(b)(4) was started. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopumonary¿s trending program and additional investigations or corrections will be implemented in case of adverse trending. The event has been reported with a delay due to our retrospective examination of the record. At the time (b)(6) 2019 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).
 
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Brand NameTUBING SETS
Type of DeviceOXYGENATOR, 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 Key11222443
MDR Text Key241237114
Report Number8010762-2021-00037
Device Sequence Number1
Product Code DTZ
Combination Product (y/n)N
PMA/PMN Number
K102726
Number of Events Reported1
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
0 Patients were Involved in the Event:
Date FDA Received01/25/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date10/29/2021
Device Model NumberHLS ADULT
Device Catalogue Number701052794
Device Lot Number70135251
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/15/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Event Location No Information
Date Manufacturer Received12/31/2019
Was Device Evaluated by Manufacturer? No
Date Device Manufactured10/30/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? Yes
Type of Device Usage

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