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

Model Number BE-PVL 2555#BE-HLS CANNULA 25F VL

Device Problems Mechanical Problem (1384); Packaging Problem (3007)

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

Event Date 08/08/2018

Event Type  malfunction  

Manufacturer Narrative

The event has been reported with a delay due to our retrospective examination of the record.At the time ((b)(6) 2017) 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)(6).The product was not need for investigation in the laboratory of the manufacturer since the failure is known and already investigated.A review of the device history record was performed with no abnormality found.As a corrective action, related to the complaint, mcp capa (b)(6) had already been opened.Packaging of hls cannulae is currently made with medical paper pouch and needs to be changed with stronger material i.E.Tyvek and better plastic film with higher tear strength.The thickness of cardboard box is also need to be increased for higher rigidity since the cardboard box working both as a shelf box and a shipper box.Based on the capa (b)(6), the most probable root causes can be defined as: packaging instructions are insufficient and the training of the instructions were not successful.Product does not own a shipper box with optimum dimensions.There is no control point for packaging integrity after mcp tr till customer.No specific shipping procedure xpo to customer and no specific packaging procedure in xpo.Health hazard evaluation (hhe) has been performed for this capa ( (b)(4)).In summary of the hhe, the identified risk is formally justifiable for this device and issue because of the seldom or unlikely likelihood of occurrence of harm.Based on this, no field action has been performed ((b)(4)).According to the hls cannulae design verification report performed on (b)(6) 2016 ((b)(4)), verification outcome of shelf life test passed acceptance criteria no visible damages of the packaging to a critical degree for further improvement in the scope of capa, the ecr (engineering change request) with the number ((b)(4)) has been initiated to change the primary packaging of hls cannuale from medical paper to tyvek blister packaging.

Event Description

It was reported that when the customer opened the sterile package it was found that there was a hole on the package.Complaint: (b)(4).

• Brand Name: HLS CANNULA
• 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: 11448048
• MDR Text Key: 243571527
• Report Number: 8010762-2021-00166
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• 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: 08/21/2018
• Device Model Number: BE-PVL 2555#BE-HLS CANNULA 25F VL
• Device Catalogue Number: 70104.7296
• Device Lot Number: 92206826
• Initial Date Manufacturer Received: 08/10/2018
• Initial Date FDA Received: 03/09/2021
• Date Device Manufactured: 08/22/2016
• Type of Device Usage: N
• Patient Sequence Number: 1