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

Model Number A24-7106

Device Problems Entrapment of Device (1212); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/19/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

According to the customer: "the stopper at the end of the cannula could not have been taken out, it was trapped in the cannula." (b)(4).

Manufacturer Narrative

Investigation has been performed in our laboratory.In the case of the visual inspection of the cannula, a broken plug has been found at the end of the cannula.The stopper is cut off in the cannula, but, it cannot be determined whether the plug is too tight or too tight in the cannula.The complaint that the stopper in the cannula has broken off can be confirmed.However, whether it was broken off by a fixed seat, by damage or material defect could not be ascertained and therefore not confirmed.Also, complaint has been investigated by (b)(4).Based on the instruction for use, it is indicated that ¿remove the vent-plug from the connector by turning it and avoid bending the vent-plug in the process.To enable smooth detachment, the vent-plug must be loosened and put back into place again before use by turning.¿the trials have been performed in an inappropriate way to the warning, and the samples were damaged similar to the complaint.A review of the device history record was performed with no abnormality found.Based on this investigation the complaint is not related to our production.A trend search has been performed (search for material (b)(4) and issue: (b)(4) connector)which came to following results: two additional complaints were recorded.Although the failure was confirmed by the laboratory, the most probable root cause could be determined as a user failure.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.This data will be handled through a designated maquet trending process.If at trend occurs, it will be escalated to qa management for review and determination if further investigation is necessary.Due to this no further action will be completed.

Event Description

(b)(4).

• Brand Name: CATHETER,CANNULA AND TUBING,VASCULAR
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; GM
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt ; 4972229321
• MDR Report Key: 6343204
• MDR Text Key: 68122317
• Report Number: 8010762-2017-00050
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K072172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/07/2019
• Device Model Number: A24-7106
• Device Catalogue Number: 701002266
• Device Lot Number: 92184506
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/18/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1