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

Model Number 10023#AVALON ELITE

Device Problem Split (2537)

Patient Problem Blood Loss (2597)

Event Date 01/23/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The device has been requested but not yet received.

Event Description

According to the customer: it was reported that on the avalon cannula it appears split on the wire wound portion during use.Surgeon was repositioning avalon dlc per md request.It has rotated that the lettering was agains the skin.Procedure was complete, new stitches places and canula position checked by echo.Pt had was turned middline, we heard a snap and blood starting squirting from neck site.Surgeon immediately applied pressure and pt was taken off bypass.Air noted in the circuit past pump head.Unable to get air out decision made get new circuit and pt would be recannulated.Perfusion and or called.Pt cannulated va with a 19 fr dlc origen cannula and a 14 fr arterial.The 19 fr dlc was not the idea cannula for this ptl.Perfusion has additional cannuals in or but did not have a 19 fr flex cannual, which we thought they had.The 19 fr and to be "y" into the venous line.They had to place a clamp onto the cannula just above the suspected fracture site and they believe additional damage was done to the cannula (to stop blood loss) that was not part of the origin(s) of the issue.But the patient is doing fine.(b)(4).

Event Description

Internal reference: (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: maquet medical systems usa (b)(4).Contact person: (b)(6).The product was requested for return to the manufacturer for laboratory investigation.The sample was received but the declaration of infection risk was missing.We requested the doir serveral times but we have not received the doir therefore no laboratory investigation could be performed by the manufacturer.This complaint will be closed since the requested doir has not been received for investigation despite several requests.The complaint will be re-opened if requested doir or any new relevant information is received.Thus the failure could not be confirmed.To determine a probable root cause is not possible at this time, because no investigation could be performed.A supplemental medwatch will be submitted after new information has been received.

• Brand Name: CATHETER
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7421883
• MDR Text Key: 105398246
• Report Number: 8010762-2018-00131
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: K081820
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 06/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10023#AVALON ELITE
• Device Catalogue Number: 701063536
• Device Lot Number: AM067213
• Date Manufacturer Received: 04/05/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1