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

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).

• Brand Name: HEMOCONCENTRATOR
• 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: 11453557
• MDR Text Key: 240612986
• Report Number: 8010762-2021-00167
• Device Sequence Number: 1
• Product Code: KDI
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K123288
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Expiration Date: 06/30/2019
• Device Model Number: BC 140 PLUS#HEMOCONCENTRATOR BC 140 PLUS
• Device Catalogue Number: 70100.2497
• Device Lot Number: 92230851
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/13/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1