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

Model Number BE-PAL 1923

Device Problems Leak/Splash (1354); Device Contamination with Body Fluid (2317)

Patient Problem No Information (3190)

Event Date 06/13/2018

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: "pal 19 fr / 23cm inside cannula, (white part) doesn´t seal properly, and blood splashed from the upper end of the cannula all over the unit.The cannula unfortunately has been disposed of by the user lot 92243432".(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 # e2018002.(b)(4).The product was not available for investigation in the laboratory of manufacturer.In addition, no visual was available regarding complaint.Sap trend search was performed (product group (b)(4), description) which came to following results: 3 additional complaint was recorded which appears reported issues are the same since the last 12 months.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,07%, which is below 1%.Due to this information, no systemic issue could be determined.According to the technical drawing, the only white part is the griff of introducer.Device history record was reviewed.There were no references found which are indicating a nonconformance of the product in question.This failure is already known to the manufacturer and has been thoroughly investigated.The most possible root cause is operator error.There is a gluing process of this part to the introducer.Operator may have performed insufficient gluing process during production and visual controls may have not been performed according to the basic operation procedure (b)(4).Based on this failure could be confirmed.As a corrective action, operators are trained and informed regarding the complaint.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

Ref.: #(b)(4).Customer ref.: (b)(4).

• Brand Name: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIO
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7654259
• MDR Text Key: 113195907
• Report Number: 8010762-2018-00222
• 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: 08/27/2018

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: 03/02/2020
• Device Model Number: BE-PAL 1923
• Device Catalogue Number: 701047287
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 06/13/2018
• Initial Date FDA Received: 07/02/2018
• Supplement Dates Manufacturer Received: 08/15/2018
• Supplement Dates FDA Received: 08/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1