MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG 10031#AVALON ELITE 31F; CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS

Model Number 701063538

Device Problems Split (2537); Noise, Audible (3273)

Patient Problem No Information (3190)

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 customer: while cannula was inserted in patient, they noticed a sucking sound and discovered the cannula had split.Patient was recannulated to another site.No reported complication.(b)(4).

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.(b)(6).The defective part has been investigated by the manufacturer: during the optical examination of the heavily soiled catheter a clot was detected during cleaning.In addition, at the beginning of the wire-reinforced section, severe damage (breakage) was found in the tube.At the point of fracture, it looks as if the hose is narrowed at this point.The wire reinforcement is not damaged.When or where this severe damage to the catheter occurred could not be clarified.No traces of a clamp could be found.A supplemental medwatch will be submitted if additional information becomes available.

• Brand Name: 10031#AVALON ELITE 31F
• Type of Device: CATHETER, CANNULA AND TUBING, VASCULAR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• MDR Report Key: 7654261
• MDR Text Key: 113195625
• Report Number: 8010762-2018-00220
• 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: 03/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 701063538
• Device Catalogue Number: 701063538
• Was Device Available for Evaluation?: Yes
• Device Age: YR
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 41 YR
• Patient Weight: 76