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

Model Number 10031#AVALON ELITE

Device Problems Device Displays Incorrect Message (2591); Gas/Air Leak (2946)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/23/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A follow-up medwatch will be submitted when additional information becomes available.(b)(4).The product was requested for return to the manufacturer for laboratory investigation but was not yet received.The investigation is still pending.

Event Description

According to the customer: the patient was on their ninth day of ecmo when the air bubble detector in the cardiohelp alarmed and it was noticed that air bubbles were in the avalon cannulae.The cannulae was clamped and the patient was outfitted with a new set and cannulae with no complications to the patient.Additional information received on (b)(6) 2019: we received that patient on vv ecmo with a 31 avalon in place on (b)(6) 2019 from (b)(6).Air incident with avalon removal on (b)(6).Air was noted in avalon access line.Both (b)(6) and ourselves do not record cannula serial numbers.We did noticed a line, crease or cut near the 28 mark.The cannula was exchange during use with no consequences for the patient.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(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).The returned avalon cannula was investigated in the laboratory of the manufacturer.An optical examination and a leak test with water were performed.In the optical examination of the cannula at the mark 28, a deformation and superficial damage (cut injury, possibly with a scalpel) were found on the tube.It could not be determined when and where this damage occurred (no prints from a hose clamp).Furthermore, blood was detected on one of the two connectors (not secured with cable ties) between the connector and the connected tube (leaking tubing connection).The tightness test of the cannula itself showed no leakage, even at the damaged spot at mark 28.Since the only leaking point on the avalon cannula is the tubing connection, only on that position could air enter the system.Thus the reported failure "air in the system" could be confirmed.But not related to our product.The most probable root cause could be the detected leakage between connector and the tube.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.Due to this no further investigation initiations will be completed at this time.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.

Event Description

Internal reference:(b)(4).

• Brand Name: CATHETER, CARDIOPULMONARY BYPASS
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 8322932
• MDR Text Key: 138995004
• Report Number: 8010762-2019-00032
• Device Sequence Number: 1
• Product Code: DWF
• Combination Product (y/n): N
• PMA/PMN Number: KK081820
• 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: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 10031#AVALON ELITE
• Device Catalogue Number: 70106.3538
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 01/24/2019
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: 01/24/2019
• Supplement Dates FDA Received: 03/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention