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

Model Number HLS CANNULAE VENOUS

Device Problem Packaging Problem (3007)

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

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

The event has been reported with a delay due to our retrospective examination of the record.At the time (2019-07-22) 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).Maquet cardiopulmonary (b)(4) did not request the product back for investigation since the issue is known.The failure is already known to the manufacturer.Maquet cardiopulmonary (b)(4) has been already initiated a corrective and preventive action, 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.The most probable root causes were identified.One of the root causes is, primary packaging consist out of medical paper pouch which do show less protection than other materials like tyvek.Based on this, engineering change request has been initiated to change sterile bag from medical paper to tyvek and strengthen cardboard box.Based on this failure could be confirmed.This complained product was manufactured before the corrective actions are implemented in corrective and preventive action.Dhr for the batches 92271179 & 92258985 were reviewed.There were no references found which are indicating a non conformance of the product in question.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary (b)(4) and further investigations and measures will be conducted in case of adverse trending.

Event Description

Customer stated that they opened 2 consecutive hls venous 23 french cannula and both had compromised sterility due to tear in each package inside the box.3rd product open was intact and they were able to continue with procedure.(b)(4).

• Brand Name: CATHETERS & CANNULAE
• 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: 11468777
• MDR Text Key: 239434511
• Report Number: 8010762-2021-00185
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102532
• 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: 03/08/2021

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: Health Professional
• Device Model Number: HLS CANNULAE VENOUS
• Device Catalogue Number: 70105.3092
• Device Lot Number: 92271179 & 92258985
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/15/2019
• Initial Date FDA Received: 03/12/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1