MAUDE Adverse Event Report: DRÄGERWERK AG & CO. KGAA VENTSTAR® COAXIAL WATER TRAP 210; BREATHING HOSE, DISPOSABLE

Catalog Number MP00373

Device Problems Obstruction of Flow (2423); Detachment of Device or Device Component (2907)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

The investigation was just started.The result will be forwarded in a follow-up report.

Event Description

It was reported that at the venstar coax watertrap hose the glued joint between the patient connector has rotated and kinked causing pressure related issues.No injury was reported.

Event Description

It was reported that at the venstar coax watertrap hose the glued joint between the patient connector has rotated and kinked causing pressure related issues.No injury was reported.

Manufacturer Narrative

For the investigation the provided circuit was analysed.The described problem could be confirmed.It was found that the adhesive connection of the outer hose had come loose.The inner circuit was still connected with the connector so that the rotation of the patient connection resulted in a twisting of the inner circuit.An error during the bonding process in production was identified as the root cause.The adhesive is applied to the connector in a semicircle and distributed by circular movements when the hose is attached.Insufficient bonding of the hoses or a broken adhesive connection can result in reduced adhesion of the hose to the respective connector.This can additionally be favored by an insufficient amount of adhesive.The manufacturer has initiated additional training for employees regarding the bonding process and has ramped up visual inspection to 100% during packaging.According to the instructions for use the breathing circuit has to be checked before use.As a result of a twisted inner circuit a blockage can occur leading to an increased airway pressure.This is detected by the connected main device and a corresponding alarm will be posted.The number of similar cases, related to the same root cause, is within the expected range of the respective risk assessment and thus accepted.

• Brand Name: VENTSTAR® COAXIAL WATER TRAP 210
• Type of Device: BREATHING HOSE, DISPOSABLE
• Manufacturer (Section D): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck ; GM
• Manufacturer (Section G): DRÄGERWERK AG & CO. KGAA; moislinger allee 53-55; lübeck 23542 ; GM 23542
• MDR Report Key: 16003518
• MDR Text Key: 306206390
• Report Number: 9611500-2022-00345
• Device Sequence Number: 1
• Product Code: BYH
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2023

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 Catalogue Number: MP00373
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/19/2022
• Supplement Dates Manufacturer Received: 01/12/2023
• Supplement Dates FDA Received: 01/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1