MAUDE Adverse Event Report: MEDIVATORS HEMOCOR HPH JUNIOR; HIGH PERFORMANCE HEMOCONCENTRATOR

Model Number	93024-256
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A user facility reported that while using the medivators hph hemocor junior filter, a pediatric patient lost approximately 20 ml of blood.Due to the size of the patient, an erythrocyte transfusion was performed.No additional patient consequences, including serious injury or deterioration of health were reported.A follow-up mdr will be filed should additional information become available.A complaint review determined this to be an isolated event.Medivators will continue to monitor for similar events to ensure the product continues to perform as expected.
Event or Problem Description
A medivators distributor of blood filters, reported that a filter leak occurred during use which resulted in approximately 20ml of patient blood loss.As the patient was pediatric, an erythrocyte transfusion was performed.No further medical intervention or adverse effect was reported.

• Brand Name: HEMOCOR HPH JUNIOR
• Common Device Name: HIGH PERFORMANCE HEMOCONCENTRATOR
• Manufacturer (Section D): MEDIVATORS; 14605 28th ave n; plymouth MN 55447
• MDR Report Key: 12284836
• Report Number: 2150060-2021-00013
• Device Sequence Number: 16865303
• Product Code: KDI
• UDI-Device Identifier: 00677964000867
• UDI-Public: 00677964000867
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K050952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 08/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 04/13/2025
• Device Model Number: 93024-256
• Device Lot Number: 458634
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/16/2021
• Initial Report FDA Received Date: 08/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1