MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG BE-PAL 2123#BE-HLS CANNULA 21F AL; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number BE-PAL 2123

Device Problem Break (1069)

Patient Problems Cardiac Arrest (1762); Hemorrhage/Bleeding (1888)

Event Date 10/06/2015

Event Type  Injury  

Manufacturer Narrative

On (b)(6) 2015 12:06 pm (gmt-5:00) added by (b)(6): (b)(4).Maquet cardiopulmonary ag requested additional information and the device in question for evaluation but has not received it yet.A supplement medwatch will be submitted as soon as additional information becomes available.

Event Description

It was reported that after insertion of the cannula device in question in the right internal jugular vein and during fixing the cannula with silk suture the device broke and it was removed.Therefore it was decided to use another femoral cannula.The patient started bleeding heavily and suffered a cardiac standstill for 10 minutes.The patient was resuscitated by using brain protection strategy and became conscious and therefore survived.(b)(4).

Manufacturer Narrative

Maquet cardiopulmonary (b)(4) requested the product for investigation and it was returned and the investigation documented in an investigation report dated (b)(4) 2015.The cannula was disinfected and cleaned with sodium hypochlorite.The product was visually inspected and it was found that the cannula was damaged (the photographic evidence clearly shows a kink in the cannula).A leakage test was performed and no leaks were found; the damaged area was watertight.There is insufficient information available to evaluate this case fully, and it has not been possible to establish how the cannula was fixed, and the details about how it was used.Only photographs of the returned product were available, and in order to reach a probable root cause, the assistance of the research and development engineer, product manager, quality engineer in turkey, and the therapy application / clinical risk manager was sought.The conclusion from the clinical assessment was that the most probable root cause is a user issue (that the product was used outside normal and expected use).Additionally, the device history record of the affected lot was investigated and no anomalies were found, and there was no scrap record found for the related material.As there is no further information available regarding this case, the exact failure mode is not known, and a search in sap found no related issues for the material number in question, no further investigation or action is warranted or possible.This is the final report.

Event Description

(b)(4).

• Brand Name: BE-PAL 2123#BE-HLS CANNULA 21F AL
• 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 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5215379
• MDR Text Key: 30981022
• Report Number: 8010762-2015-01159
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• Reporter Country Code: SA
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/17/2017
• Device Model Number: BE-PAL 2123
• Device Catalogue Number: 70104.7288
• Device Lot Number: 92166501
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/23/2015
• Initial Date FDA Received: 11/10/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/02/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2015
• 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
• Patient Outcome(s): Required Intervention