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

Model Number A20-0106#ART.CANNUL

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Maquet medical systems, usa submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).A follow-up medwatch will be submitted when additional information becomes available.

Event Description

Complaint concerning aortic cannula ad-20fr (6,7mm) ref: (b)(4).Cannula located in the patient, the end of the venting plug was broken and the remainder in the cannula could not be removed so that this cannula was removed.A new one had to be placed.Furthermore, the cannula had to be deaerated more elaborately since there is a foam formation directly below the ventilation plug.Therefore we have pulled out the remaining stock of cannulas of this type (14 pieces).The cannula with the aborted, also made stoppers so that they can be imprinted.No damage to the patient.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for manufacturer investigation at least three times from the ssu.Unfortunately, there were no more detailed information and no pictures about the complaint and the sample was not returned to us for investigation.A sap trend search has been performed (search for material 70100.2208 and issue: 0433 vent plug) which came to following results: no additional complaints were recorded.Also,an open search of the trackwise complaints database using the material number 70100.2208 was carried out and the searched returned no complaints.Based on the trending for material number, a systemic issue is not indicated.According to the instruction for use, in the ¿warnings and precautions¿ part, 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.¿.It could be possible that the device could not be used in according to the ifu.A review of the device history record was performed with no abnormality found.The most probable root cause could be related to a user failure.Because, if the process mentioned in instruction for use performed, the vent plug would be broken before treatment.This situation shows that the product was not used according to the ifu warning.Therefore, the failure was not confirmed.This data will be handled through a designated maquet trending process.If at trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further action will be completed at this time.

Event Description

Ref: (b)(4), customer ref: (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: 6813639
• MDR Text Key: 83626928
• Report Number: 8010762-2017-00272
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K072172
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/13/2017

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 Expiration Date: 09/07/2019
• Device Model Number: A20-0106#ART.CANNUL
• Device Catalogue Number: 701002208
• Device Lot Number: 92190074
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/08/2017
• Initial Date FDA Received: 08/23/2017
• Supplement Dates Manufacturer Received: 08/08/2017
• Supplement Dates FDA Received: 10/13/2017
• Date Device Manufactured: 09/01/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1