MAUDE Adverse Event Report: WELLSKY CORPORATION HCLL TRANSFUSION 2015 CS

Device Problems Device Alarm System (1012); Compatibility Problem (2960)

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

Event Date 09/17/2020

Event Type  malfunction  

Event Description

During use of wellsky transfusion 2015 cs, an a+ red blood cell was electronically crossmatched to an o+ patient.Transfusion 2015 cs worked as designed at product issue, displaying in product fulfillment as not trdy (transfusion ready).Transfusion recorded a compatable crossmatch and did not provide the "hard stop" warning at time of product selection.Approximately 200cc of a+ blood was administered to an o+ patient.The error was discovered through client review of product exceptions.Upon discovery the transfusion was terminated.The patient did not experience any adverse reaction caused by the transfusion.To date, the event has not been reproduceable by wellsky or the reporting client.

• Brand Name: HCLL TRANSFUSION 2015 CS
• Type of Device: HCLL TRANSFUSION 2015 CS
• Manufacturer (Section D): WELLSKY CORPORATION; 11300 switzer rd; overland park KS 66210
• Manufacturer (Section G): WELLSKY CORPORATION; 11300 switzer rd; overland park KS 66210
• Manufacturer Contact: jon moeckel ; 11300 switzer rd; overland park, KS 66210 ; 9133071000
• MDR Report Key: 11517375
• MDR Text Key: 244162934
• Report Number: 3006129391-2020-00001
• Device Sequence Number: 1
• Product Code: MMH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK160066
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Modification/Adjustment
• Type of Report: Initial
• Report Date: 09/28/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/02/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other