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

Model Number A24 7106

Device Problem Device Dislodged or Dislocated (2923)

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

Event Date 02/10/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: stopper of the cannule was trapped in the cannule.The event occurred during operation.Due to the reported problem , the cannule had to be disconnected from the patient, even though it had been inserted.(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 broken vent plug cannot be pulled out of the connector without tools,since the head is missing.The complaint that the stopper in the cannula has broken off can be confirmed.Also, complaint has been investigated by maquet (b)(4).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.¿ 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.According to this investigation the complaint is not related to our production,the most probable root cause could be determined as an 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.A trend search has been performed which came to following results: two additional complaints were recorded.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 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

(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: 6399314
• MDR Text Key: 70061826
• Report Number: 8010762-2017-00079
• 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: 05/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2018
• Device Model Number: A24 7106
• Device Catalogue Number: 701002266
• Device Lot Number: 92178134
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/25/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/01/2015
• 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