MAUDE Adverse Event Report: PRODUCTOS MEDLINE, S.A. DE C.V.; LEFT HEART KIT

Catalog Number VASC1131

Device Problems Crack (1135); Improper Flow or Infusion (2954)

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

Event Date 09/23/2020

Event Type  malfunction  

Manufacturer Narrative

It was reported that there were cracked transducer connections which led to blood flowing back into the manifold throughout the case.No additional details are available related to the customer reported issue.The customer contact was unwilling to provide further incident details to the manufacturer.No sample was returned for evaluation.No additional information is available.Due to the reported incident and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.

Event Description

It was reported that there were cracked transducer connections which led to blood flowing back into the manifold throughout the case.

• Type of Device: LEFT HEART KIT
• Manufacturer (Section D): PRODUCTOS MEDLINE, S.A. DE C.V.; blvd. world trade center no. 1; parque industrial oradel; nuevo laredo, tamaulipas 88285 ; MX 88285
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093-2753
• MDR Report Key: 10824071
• MDR Text Key: 234147229
• Report Number: 3004122598-2020-00003
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 10889942854325
• UDI-Public: 10889942854325
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/11/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VASC1131
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/27/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other