MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number JS 49 RD#SUCTION DEVICE ID = 4.9 MM

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/19/2017

Event Type  malfunction  

Manufacturer Narrative

The event has been reported with a delay due to our retrospective examination of the record.At the time (2017-04-20) 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).It was reported that the weld seams are not thick enough so that the product comes out of the package even at the smallest movement.Maquet cardiopulmonary requested the product for manufacturer investigation.For the claimed batch 92204212, a box has been received and investigated by laboratory.There are 10 products for each box.The weld should be 6mm wide.During the investigation of the sterile bag, the weld seam of the tyvek under cover and the upper foil was pulled about 2 mm wide, and about 2 cm long apart.The welded seam is still welded 4mm.The sterility still maintains, no open space visible.However, this packaging is not suitable based on the basic operation procedure.The reported failure "the weld seams are not thick enough" can be confirmed.This complaint was investigated and closed on 2018-05-15.There is no maintenance record related to the packaging machine during production date of the claimed lot.The machine was working properly.Also, there is no nonconformity and no scar (supplier corrective action request) related to the claimed material.For more detailed investigation related to the packaging machine, a non-conformance was opened nc (b)(4).Also,the samples were tested by mcp r&d department.The root causes were defined as below in the nc (b)(4): equipment / machine failure, process failure, calibration failure, operator failure.As part of the investigation of this nc the following actions have been taken: equipment's mold holes were widened for m8 bolts.M8 hex head bolts and serrated lock washers were mounted, calibrations were defined for parameters, calibration requirements determination forms were created for related machines, daily sealing control form was revised.Two control points were added in the form, employees were trained.Device history record of the complained lot 92204211 has been reviewed and no abnormality was found.For more detailed investigation related to the packaging machine,a non-conformance was opened nc (b)(4).All variants of suction devices were phased out in 2018 due to marketing decision (dms #(b)(4) v1).The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary´s trending program and additional investigations or corrections will be implemented in case of adverse trending.

Event Description

It was reported that the weld seams are not thick enough so that the product comes out of the package even at the smallest movement.Complaint: #(b)(4).

• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• 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: 11453559
• MDR Text Key: 239733823
• Report Number: 8010762-2021-00171
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K020983
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial
• Report Date: 03/09/2021

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 Expiration Date: 01/25/2020
• Device Model Number: JS 49 RD#SUCTION DEVICE ID = 4.9 MM
• Device Catalogue Number: 70101.2153
• Device Lot Number: 92204212
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 03/10/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/26/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1