MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH TUBING SETS AND COMPONENTS WITH OR WITHOUT SOFTLINE COATING; TUBING, PUMP, CARDIOPULMONARY BYPASS

Model Number CUSTOM TUBING SET

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/22/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''the silicone pump boot of the neonatal bypass set (lot 92262611) had a split in it that was only noticed during cardiopulmonary bypass when it started leaking.The patient was on cardiopulmonary bypass with the heart arrested so we cooled the patient and came off bypass for one minute to change out the pump boot.'' complaint #411658.

Manufacturer Narrative

It was reported that the silicone pump boot of the neonatal bypass set (lot: 92262611) had a split in it that was only noticed during cardiopulmonary bypass when it started leaking.The affected product was investigated in the laboratory of the manufacturer on 2021-04-08.Based on the test result it can be confirmed that there is a hole in the tubing section, which leads to blood leakage.Further, it could be determined that modifications on the tubings and cable ties were performed by the customer.The affected section is not in accordance with specification the technical drawing.The exact root cause could not be determined.However, the hole might have been accidentally caused by the customer during the modification.The technical drawing had already been revised on (b)(6) 2019 based on the customer demand, before the complaint was received.Device history record for lot: 92262611 was reviewed on 2021-01-07.There are no evidences indicating non-conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Production-related influences can be excluded.The occurrence rate was calculated for the reported issue and it was determined that this is not a systemic issue.Therefore, no remedial action is required.Based on the investigation so far, the failure could be confirmed.However, the exact root cause could not be identified.The most probable root cause was determined as user error.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 AND COMPONENTS WITH OR WITHOUT SOFTLINE COATING
• Type of Device: TUBING, PUMP, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11170043
• MDR Text Key: 226794488
• Report Number: 8010762-2021-00012
• Device Sequence Number: 1
• Product Code: DWE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CUSTOM TUBING SET
• Device Catalogue Number: 70104.9158
• Device Lot Number: 92262611
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1