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

Model Number BE-PLV 2555

Device Problems Difficult to Insert (1316); Fitting Problem (2183)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/18/2019

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

"during the preparation for the cannulation, it was unable to insert the introducer into the cannula.The surgeon felt the cannula was smaller than usual.The procedure was completed with a replacement.No adverse effects on the patient." (b)(4).

Event Description

Ref.:(b)(4).

Manufacturer Narrative

Maquet medical systems,usa(importer)submits this report on behalf of the legal manufacturer of the device maquet cardiopulmonary (b)(4).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).Maquet cardiopulmonary gmbh was requested the product back for investigation in laboratory of manufacturer.A venous hls cannula 25 fr.And an introducer were received back.Application was performed.The introducer could be inserted perfectly into the hls cannula.Based on the information available at this time the cause of this failure was determined to not be attributed to a device related malfunction.The root cause of the failure could not be identified.The problem is deemed as not reproducible.In addition, getinge cp antalya investigated the complaint and no production problem could be found.Device history record was reviewed.There were no references found, which are indicating a nonconformance of the product in question.A sap trend search was performed (production group 40000 catheter, failure code 1012 fitting problems) and 2 additional complaints were found which are in status of 'not confirmed' and appears reported issues are the similar since the last 12 months.No additional complaint, reporting the same failure for the reported lot, was found.Based on the sales figures of the last 12 months following occurrence rate has been calculated: 0,02%, which is below than 1%.Due to this information no systemic issue could be determined.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.

• Brand Name: CATHETER,CANNULA&TUBING,VASCULAR,CARDIOPULMONARY
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8302237
• MDR Text Key: 137006187
• Report Number: 8010762-2019-00023
• 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: 03/26/2019

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: 03/08/2020
• Device Model Number: BE-PLV 2555
• Device Catalogue Number: 701047296
• Device Lot Number: 92247526
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/14/2019
• Initial Date Manufacturer Received: 01/25/2019
• Initial Date FDA Received: 02/04/2019
• Supplement Dates Manufacturer Received: 01/25/2019
• Supplement Dates FDA Received: 03/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1