MAUDE Adverse Event Report: MEX03 MEXICO-JUAREZ PRESOURCE DESERT SPRING HEART 1 AND 2 PK(OHDSC)839; CARDIOVASCULAR PROCEDURE KIT

Model Number	SCV73OHDSD
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/02/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
From the device history record, lot# 20200206-25-sh was manufactured on 31st dec 2019.No exception was recorded in the device history record that could lead to the reported incident.Based on supplier investigation, device history record (dhr) review did not indicate any exception that could lead to the reported incident.Supplier checked on their retained sample, it is normal and no lint was found.There were 2 occurrences reported in the past 12 months.No sample was returned for investigation.According to the supplier, product ls1818ps are pre-washed.The workers shall do the visual test for every piece of product before folding and remove unqualified product.They do sampling inspection during the process and for the final products.From the investigation, there is no abnormal situation happened in production, with retained sample or with the device history record.Therefore, the root cause could not be determined.The complaint information was informed to the relevant sectors for their awareness.There is no action taken at this time, but supplier will continue to monitor the trend of this type of incident.
Event or Problem Description
Customer reported that during an open heart procedure the lap sponges ls1818psa from the heart pack scv73ohdsd had a lot of lint so they were removed and not used for the case.There was no delay and no injury.No patient demographics were provided upon request.

• Brand Name: DESERT SPRING HEART 1 AND 2 PK(OHDSC)839
• Common Device Name: CARDIOVASCULAR PROCEDURE KIT
• Manufacturer (Section D): MEX03 MEXICO-JUAREZ PRESOURCE; c. arcadia 1580 , col. terraza; cd.juarez , chihuahua CP 32 599; MX CP 32599
• MDR Report Key: 10218318
• Report Number: 1423537-2020-00474
• Device Sequence Number: 16854562
• Product Code: OEZ
• UDI-Device Identifier: 10888439631432
• UDI-Public: 10888439631432
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/01/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SCV73OHDSD
• Device Catalogue Number: SCV73OHDSD
• Device Lot Number: 420635
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/02/2020
• Initial Report FDA Received Date: 07/01/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other