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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 02/27/2019
Event Type  malfunction  
Manufacturer Narrative
It has been reported with a delay due to our retrospective examination of the record. At the time (2019-03-01) 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). Sample investigation is not necessary since there is a similar complaint (#(b)(4)) and sample investigation results. According to the results of this complaint investigation: maquet cardiopulmonary (b)(4) was received the product back for investigation. During the visual examination of the sterile bag several damages, also a hole in the foil, were noticed on the clear side. On the paper side of the sterile packaging also a hole was found. The sterility of the packed in the sterile bag blutport cap tight is therefore not possible. No defects were found on the bc 140 plus. Based on this,the failure could be confirmed. 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 mcp ag 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. According to the received information by an r&d engineer: 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 an tyvek based blister packaging. Therefore in this case two possible causes are could be determined. It is hard to determine the exact cause of the failure. Rc1: packaging failure during production. Rc2: material/design failure. Device history record was reviewed. There were no references found, which are indicating a nonconformance of the product in question. As a corrective action, getinge cp antalya has trained the operators to be more careful about packaging process and visual checks. 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 tyvek side of the cap package was 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 Key11459426
MDR Text Key239092191
Report Number8010762-2021-00180
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 Model NumberBC 140 PLUS#HEMOCONCENTRATOR BC 140 PLU
Device Catalogue Number70100.2497
Device Lot Number92230851
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/27/2019
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured07/01/2017
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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