MAUDE Adverse Event Report: MEDTRONIC MEXICO AUTOLOG WASH KIT; APPARATUS, AUTOTRANSFUSION

Model Number ATL2001

Device Problem Burst Container or Vessel (1074)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 12/18/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation conclusion: an analysis of this occurrence could not be performed without the returned product.After evaluation the cause of this complaint could not be determined.Review of the device history record found no abnormalities during manufacturing that would cause or contribute to the reported event.Complaints received from oct,20 through jan,21 for the same failure mode were reviewed and showed no trends warranting escalation related to this occurrence.Medtronic has made its supplier aware of this occurrence and will continue to monitor for future occurrences and trends.If information is provided in the future, a supplemental report will be issued.

Event Description

Medtronic received information that during use of two autolog washkits, the customer reported that the roller pump head tubing was burst only after a few rotations.Both washkits were used during the same case.The devices were replaced with another set.The customer had to discontinue the cell saver usage even when it was required for autologous blood.

• Brand Name: AUTOLOG WASH KIT
• Type of Device: APPARATUS, AUTOTRANSFUSION
• Manufacturer (Section D): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer (Section G): MEDTRONIC MEXICO; av. paseo del cucapah #10510; tijuana,bc 22570 ; MX 22570
• Manufacturer Contact: toni o'doherty ; parkmore business park west; galway ; EI ; 091708734
• MDR Report Key: 11419639
• MDR Text Key: 235000766
• Report Number: 9612164-2021-00876
• Device Sequence Number: 1
• Product Code: CAC
• UDI-Device Identifier: 00613994520456
• UDI-Public: 00613994520456
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K093535
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/05/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/28/2021
• Device Model Number: ATL2001
• Device Catalogue Number: ATL2001
• Device Lot Number: 217751016
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/04/2021
• Date Device Manufactured: 05/28/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1