MAUDE Adverse Event Report: HAEMONETICS CORPORATION HAEMONETICS RESERVOIR; HAEMONETICS RESERVOIR CELL SAVER SYSTEM

Catalog Number 205

Device Problems Material Separation (1562); Device Inoperable (1663); Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); Packaging Problem (3007)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2014

Event Type  malfunction  

Event Description

The first issue is with the reservoir.We have been having trouble with reservoirs for approximately 1 year with various lot numbers.We were finding several reservoirs where the filter had separated from the reservoir itself.After sending back numerous reservoirs haemonetics told us to manually go in and order a certain lot number that did not have this issue.From my understanding they used a different plastic and were having trouble.In order not to get broken filters we would order a newer lot which did not have the plastic problem.Since we started ordering the non-affected reservoirs our issue is pretty much solved concerning the reservoir.Our other extremely frustrating issue is with the leukocyte reduction filter.We started having issues with the flow rate about 8-10 months ago.We simply could not get the filter to run.We could prime the first side but as soon as the second side started to fill it would stop running.This was not lot specific.On one occasion we sent 3 used filters back to haemonetics to be evaluated.This was not an easy task.We had to store 3 bloody filters in the lab until the company could send us biohazard containers to ship them.We received word that they got the filters but found nothing.The company's suggestion is to continue to call them when this happens and they will file a complaint.They would like us to save the used filters and they will send us the packaging for us to mail them back to them.This filter issue does not happen all the time but often enough that we dread it when we have to use it because we anticipate issues.It really is a huge problem for us.It is also not practical to hold on to bloody filters until we get the proper packaging from the company.

• Brand Name: HAEMONETICS RESERVOIR
• Type of Device: HAEMONETICS RESERVOIR CELL SAVER SYSTEM
• Manufacturer (Section D): HAEMONETICS CORPORATION; 400 wood road; braintree MA 02184
• MDR Report Key: 4083529
• MDR Text Key: 4828359
• Report Number: 4083529
• Device Sequence Number: 1
• Product Code: CAC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/08/2014
• 2 Devices were Involved in the Event: 1 2

1 Patient was Involved in the Event

• Date FDA Received: 08/08/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Invalid Data
• Device Catalogue Number: 205
• Device Lot Number: 1304006AH
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: NO OTHER THERAPIES