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 Sticking (1597)

Patient Problem No Information (3190)

Event Date 01/30/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "stopper of the cannula was trapped in the cannula.It has been informed that due to the customer has experienced the same issue often,they inspect the cannula before usage by taking the stopper out and into the cannula.On (b)(6) 2017, the customer has reported that stopper at the end of the cannula could not been taken out,it was trapped in the cannula.The stopper had been tried to be taken out via a needle, and then it had run into the cannula." (b)(4).

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # e2018002.(b)(4).This complaint was reopened because of the reporting decision was changed.A visual inspection of the received pictures show that the vent plug was trapped in the cannula.A review of dhr was performed with no abnormality found.A trend search was performed related to same failure,which came to following results:6 additional complaints were recorded.The (b)(4) is created within the scope of capa (b)(4) that was triggered by similar customer complaints.The likelihood of occurrence of the failure mode ¿vent cap brakes¿off is (b)(4) considering a total number of 7 reported cases in the time period between 2017-01-01 and 2018-01-31 and (b)(4) sold products in the same time complaints.The on the ifu the operator has to detach the vent plug by applying a pull-rotation movement and the operator is warned to avoid bending the vent plug.Bending tests have shown that the broken edge of a vent plug,which was bended,has a slanted pathway.The broken edges of the complained items show also a slanted pathway.Therefore,the operator was most likely bending the vent plug,which caused the malfunction.Regarding the vent plug there were no material strengths defined.Therefore,the production process at the supplier is not validated and therefore a likelihood of occurrences is not determinable.The malfunction is caused by an interaction of varying material strengths and the handling of the operator.A tensile test,an investigation report and a sheartest showed that no vent plug neither out of a complained batch nor a newer batch failed by applying the pull-rotate movement as described in the ifu.Additionally there is no information available how plug was not considered within the design verification.The problem addressed in this hhe is systematic as it is the consequence of device design.

Event Description

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: 7434211
• MDR Text Key: 105882077
• Report Number: 8010762-2018-00135
• 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: 06/13/2018

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: 06/07/2019
• Device Model Number: A24-7106
• Device Catalogue Number: 701002266
• Device Lot Number: 92184506
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2017
• Initial Date FDA Received: 04/16/2018
• Supplement Dates Manufacturer Received: 06/13/2018
• Supplement Dates FDA Received: 06/13/2018
• 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: N
• Patient Sequence Number: 1