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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM

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MAQUET CARDIOPULMONARY GMBH HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS DIALYZER, HIGH PERMEABILITY WITH OR WITHOUT SEALED DIALYSATE SYSTEM Back to Search Results
Model Number BC 140 PLUS#HEMOCONCENTRATOR BC 140 PLU
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2019
Event Type  malfunction  
Manufacturer Narrative
It has been reported with a delay due to our retrospective examination of the record. At the time (2019-03-21) 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 2019-05-13 for investigation in the laboratory of manufacturer. In visual inspection of the complaint sample, a hole was found on the sterile bag (b)(4), 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. Also,adhesive failure was detected on one sample. 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 (b)(4) 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. In addition, for the adhesive failure on the body of the one product, the most probable root cause found as material failure. Device history record was reviewed. There were no references found, which are indicating a nonconformance of the product in question. The occurrence rate was calculated for the reported failure and product and it was determined that this is not a systemic issue. Therefore, no remedial action is required.
 
Event Description
It was reported that the package of the accessory cap for 2 products were torn. Complaint: #(b)(4).
 
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Brand NameHEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS
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 Key11459429
MDR Text Key239092889
Report Number8010762-2021-00181
Device Sequence Number1
Product Code KDI
Combination Product (y/n)N
PMA/PMN Number
K123288
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial
Report Date 03/11/2021
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/11/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date09/07/2019
Device Model NumberBC 140 PLUS#HEMOCONCENTRATOR BC 140 PLU
Device Catalogue Number70100.2497
Device Lot Number92228535
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2019
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/08/2019
Is the Device Single Use? No Answer Provided
Is This a Reprocessed and Reused Single-Use Device?
Type of Device Usage Initial

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