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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number BC 140 PLUS#HEMOCONCENTRATOR BC 140 PLUS
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/20/2019
Event Type  malfunction  
Manufacturer Narrative
The event has been reported with a delay due to our retrospective examination of the record. At the time (2019-03-14) 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). Product was received on 2019-04-02 for investigation in the laboratory of manufacturer. In visual inspection of the complaint sample, a hole was found on the sterile bag 700004149, the package of the cap. This damage affects the sterility of the product therefore product cannot be used. The failure torn on the package of the cap can be confirmed. No failure was found on the package of the hemoconcentrator itself. The complaint was also investigated by getinge cp antalya. Investigation shows that the failure could be occurred during packaging process and not be noticed by operators. Operators may not be careful about visual controls. Also regarding similar issues maquet cardiopulmonary gmbh has been initiated a capa(b)(4) based on several complaints showing the same symptoms with different material numbers than the one in this complaint, in order to determine the root cause and initiate further actions to determine corrective measures for the failure. Possible cause, which needs to verify with ongoing packaging test, design/ material of current sterile bag of the tight cap. Possible action design/ material change into a tyvek based blister packaging. Device history record was reviewed. There were no references found, which are indicating a nonconformance of the product in question. The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonarys trending program and additional investigations or corrections will be implemented in case of adverse trending.
 
Event Description
It was reported that the customer found the package of the device and the accessory cap were torn. Complaint: #(b)(4).
 
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Brand NameHEMOCONCENTRATOR
Type of DeviceDIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM
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 Key11453557
MDR Text Key240612986
Report Number8010762-2021-00167
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K123288
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 03/10/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date06/30/2019
Device Model NumberBC 140 PLUS#HEMOCONCENTRATOR BC 140 PLUS
Device Catalogue Number70100.2497
Device Lot Number92230851
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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