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 02/28/2019

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).

• 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: 11459429
• MDR Text Key: 239092889
• Report Number: 8010762-2021-00181
• 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

• Date FDA Received: 03/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 09/07/2019
• Device Model Number: BC 140 PLUS#HEMOCONCENTRATOR BC 140 PLU
• Device Catalogue Number: 70100.2497
• Device Lot Number: 92228535
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/08/2019
• Type of Device Usage: Initial
• Patient Sequence Number: 1