MAUDE Adverse Event Report: MEDIVATORS INC. HEMOCOR HPH400; HEMOCONCENTRATOR

Model Number	HPH 400
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Blood Loss (2597); No Known Impact Or Consequence To Patient (2692)
Date of Event	08/08/2018
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4), distributor of hemocor hemoconcentrators, reported on behalf of a user facility that while using a medivators hph 400 hemoconcentrator, a pediatric patient lost about 100 ml of blood.It was reported that after unclamping the effluent line, the patient blood was sucked to the wall of the waste container as a result of a fiber leak.The patient did not experience any symptoms as a result of the blood loss, there was no delay in the procedure and no medical intervention was required.The hemoconcentrator was returned to medivators for quality assurance investigation.The reported fiber leak was confirmed.Medivators remains in close contact with terumo.This complaint will continue to be monitored in the medivators complaint handling system.
Event or Problem Description
(b)(4), distributor of hemocor hemoconcentrators, reported on behalf of a user facility that while using a medivators hph 400 hemoconcentrator, a pediatric patient lost about 100 ml of blood.There was no effect on the patient.

• Brand Name: HEMOCOR HPH400
• Common Device Name: HEMOCONCENTRATOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7857354
• Report Number: 2150060-2018-00060
• Device Sequence Number: 11097434
• Product Code: KDI
• UDI-Device Identifier: 00677964011207
• UDI-Public: 00677964011207
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K923139
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,health profession
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 11/01/2022
• Device Model Number: HPH 400
• Device Lot Number: 883617
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/09/2018
• Initial Report FDA Received Date: 09/07/2018
• 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