MAUDE Adverse Event Report: HAEMONETICS CORPORATION SOFTWARE SOLUTIONS ELDORADO DONOR 3.0.0; BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES

Model Number EDD3.0.0

Device Problem Programming Issue (3014)

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

Event Date 09/26/2016

Event Type  malfunction  

Manufacturer Narrative

It was initially identified in the investigation that the prohibiting factors for 'lowvol' were not in place on the user table setup.The customer's initial mitigation after the issue was discovered was to add a prohibiting factor to the 'lowvol' failure codes so that any subsequent donations recorded with this failure code will allow the defined draw failure prohibiting factor to post to those failed donations.The investigation is not complete and no root cause of the issue has been identified.A supplemental report will be submitted upon conclusion of the investigation.Software issue, no device available.

Event Description

The customer reported on (b)(6) 2016 that an untested donation rbc component was able to be labeled based on the donor record's historic blood type without the eldorado donor application requiring an override.The donor had been collected off-line (i.E.On a paper medical history form) and there was a problem with the donor's initial phlebotomy needle stick.The staff member entered the 'lowvol' draw failure code on the medical history form for that initial inadequate donation draw.Subsequently, a second phlebotomy stick was successful and a full donor unit was collected and the draw information was entered on the same paper medical history form that had been used for the initial needle sick.However, the initial stick's 'lowvol' draw failure code was not removed (in error) from.When the draw information for the successful second collection attempt was entered into the eldorado donor application, the data entry user entered the 'lowvol' draw failure code and met the successful full donor unit.The 'lowvol' failure code was not mapped in the user table setup to post a prohibiting factor nor was it defined to require unit testing or draw information.Because there was no prohibiting factor defined to post, and this failure code was defined to not require unit testing, there were no conditions associated to the component manufacture record to prevent the untested donation to be identified.This donor had a historical blood type on record and the application allowed the rbc component to be labeled based on the donor's historic blood type when no current test results had been received for that donation.The customer found the issue just prior to shipping this untested rbc component to their end user.The customer subsequently provided the information that of the original four cases, the initial case was caught and stopped at shipping.The other three cases all had components distributed and transfused, however the customer verified testing from donations prior to and following the problem units and all routine donor testing is acceptable.No adverse transfusion reactions were reported.

• Brand Name: ELDORADO DONOR 3.0.0
• Type of Device: BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
• Manufacturer (Section D): HAEMONETICS CORPORATION SOFTWARE SOLUTIONS; 4925 robert j. matthews parkwa; suite 100; el dorado hills CA 95762
• Manufacturer (Section G): HAEMONETICS CORP; 400 wood rd; braintree MA 02184
• Manufacturer Contact: julie smith, rn ; 400 wood rd; braintree, MA 02184 ; 7819170643
• MDR Report Key: 6055315
• MDR Text Key: 58772609
• Report Number: 2951268-2016-00001
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150308
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/26/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Phlebotomist
• Device Model Number: EDD3.0.0
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/26/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/25/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1