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

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).

• Brand Name: HEMOCONCENTRATOR BC 60 PLUS, BC 140 PLUS
• Type of Device: DIALYZER, 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 Key: 11459426
• MDR Text Key: 239092191
• Report Number: 8010762-2021-00180
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• PMA/PMN Number: K123288
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: BC 140 PLUS#HEMOCONCENTRATOR BC 140 PLU
• Device Catalogue Number: 70100.2497
• Device Lot Number: 92230851
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/11/2021
• Date Device Manufactured: 07/01/2017
• Type of Device Usage: Initial
• Patient Sequence Number: 1