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

Model Number BE-PAS 2115

Device Problem Defective Component (2292)

Patient Problem No Patient Involvement (2645)

Event Date 05/22/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "customer makes bfarm message due to a defective dilator of a 21/15 hls cannula.The customer just wanted to use this cannula.But since the dilator was defective, he could not use the cannula.There was no patient contact with the cannula." (b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary ag kehler strasse 31, 76437 rastatt, germany.A follow-up medwatch will be submitted when additional information becomes available.Reference exemption # (b)(4).Importer- maquet medical systems usa (b)(4).Contact person- (b)(6).The sample was received on 2018-07-17 but a full investigation was unable to be performed as the declaration of infection risk shows the complaint sample has a risk group 3.Depending on the situation, the sample cannot opened and the laboratory cannot investigate the sample.However, the investigation was performed based on received complaint picture.Device history record of the complaint lot was reviewed.There were no references found which are indicating a nonconformance of the product in question.Trend search was performed (material 70104.7283 and similar failure) which came to following results:no additional complaint was recorded since the last 12 months.(b)(4).Due to this information no systemic issue could be determined.The steps of production were reviewed.The operators perform this process according to the basic operation procedure "sterile bag packaging and labelling for cannula".There is no assembly process related to the complained part.Additionally, all the products are controlled visually.No similar complaint investigated was found which could led to the exact root cause of the failure and a product related malfunction.The original packaging could not be inspected as it was not delivered by the hospital.The failure could be related to external physical force on the product.The most probable cause of the failure is unknown at this time.The products could be damaged during delivery period or in the hospital.Since the reported failure did not contribute to a death or serious injury no corrective action is needed.In addition at this time it cannot be concluded that this is a systemic error.No corrective action is needed.The failure could not be confirmed.

Event Description

Ref.: (b)(4).

• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7670696
• MDR Text Key: 113745037
• Report Number: 8010762-2018-00226
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K102532
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 09/05/2018

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: 12/03/2019
• Device Model Number: BE-PAS 2115
• Device Catalogue Number: 701047283
• Device Lot Number: 92232421
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/17/2018
• Initial Date Manufacturer Received: 06/20/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 08/27/2018
• Supplement Dates FDA Received: 09/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1