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

Model Number BE-PAS 1915

Device Problems Difficult to Insert (1316); Physical Resistance (2578)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/17/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the hospital: "the device was used for femoral cannulation.The customer felt resistance when inserting the cannula.He tried for several times, but it didn't go through.He replaced it with another cannula to continue the procedure.No adverse effects on the patient.Occurred during patient use.".

Event Description

(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.Importer- (b)(4).According to the complaint report the device was not available for investigation in the laboratory of manufacturer.The device was disposed at the hospital.Sap trend search was performed (material 70104.7282, failure code 1012 fitting problems) which came to following results: 0 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: 0,03%, which is below 1%.Due to this information no systemic issue could be determined.The received information was not sufficient to determine the root cause of the failure.Also no answer was able to obtain to our questions.The information obtained so far in this investigation would confirm that the device met its specification at the time of manufacturing.At this time no similar complaint investigated was found which could led to the confirmation of the failure and / or a product related malfunction.Based on this failure could not be confirmed.Device history record was reviewed.There were no references found which are indicating a non-conformance of the product in question.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.

• Brand Name: HLS VENOUS CANNULA
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7122051
• MDR Text Key: 95800711
• Report Number: 8010762-2017-00398
• 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: 07/31/2018

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: 10/05/2018
• Device Model Number: BE-PAS 1915
• Device Catalogue Number: 701047282
• Device Lot Number: 92208890
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 12/15/2017
• Supplement Dates Manufacturer Received: 07/20/2018
• Supplement Dates FDA Received: 07/31/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1