MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number BE-MECC 101403#MECC SYSTEM W/O RESERVOIR

Device Problem Tear, Rip or Hole in Device Packaging (2385)

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

Event Date 08/25/2023

Event Type  malfunction  

Manufacturer Narrative

A follow-up medwatch will be submitted when further information becomes available.

Event Description

It was reported that after opening the white box, during the incoming inspection at distributor warehouse, staff discovered that the tyvek was perforated.The product was not used on patient.No harm to any person was reported.Complaint #(b)(4).

Manufacturer Narrative

It was reported that after opening the white box, during the incoming inspection at distributor warehouse, staff discovered that the tyvek was perforated.The product was not used on patient.No harm to any person has been reported.The sample investigation is not required at this time.The reported failure is already known by manufacturer and the provided pictures within the complaint show the reported failure clearly.Based on this, the failure could be confirmed.The production history records (dhrs) of the affected be-mecc 101403 with lot# 3000322774 was reviewed on 2022-09-11.According to the dhr results, the product be-mecc 101403 passed the defined manufacturing and final release specifications.Further, quality hold has been initiated for the product ¿be-mecc 101403 / 701075208¿.Capa has been initiated for the reported failure ¿hole at tyvek / tyvek perforated¿ and for the reported product ¿be-mecc 101403 / 701075208¿.The root cause analysis and further actions to determine corrective measures for the failure will be performed within the capa.All further steps will be performed in accordance to capa.Based on the investigation results, the probable causes have been found as: transport / stationary: unknown transport conditions.Manufacture failure: loose velcro strap connection by manufacture employee.Design failure: single velcro strap usage is not qualified for the related set therefore velcro strap becomes loose.The detailed root cause analysis will be performed within capa.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

Complaint #(b)(4).

• Brand Name: TUBING SETS
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17709793
• MDR Text Key: 322938635
• Report Number: 8010762-2023-00445
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K080592
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-MECC 101403#MECC SYSTEM W/O RESERVOIR
• Device Catalogue Number: 701075208
• Device Lot Number: 300031551
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 06/15/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other