MAUDE Adverse Event Report: MEDIVATORS INC. HEMOCOR HPH JUNIOR HEMOCONCENTRATOR

Model Number	HPH JUNIOR
Medical Device Problem Code	Detachment of Device or Device Component (2907)
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	08/20/2018
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 hph junior hemoconcentrator during a bypass procedure, a pediatric patient lost less than 10 ml of blood.The blood loss was reported to be due to a leak out of the header cap.There were no adverse effects as a result of the reported complaint.Medivators followed up for more information, but (b)(4) reported there is very limited information available regarding this complaint.There was no report of medical intervention, any symptoms experienced or delay in the procedure.The hemoconcentrator was returned to medivators for quality assurance investigation.The reported header cap leak was confirmed.Medivators has not received any complaints similar to this report.Medivators remains in close contact with (b)(4).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 hph junior hemoconcentrator during a bypass procedure, a pediatric patient lost less than 10 ml of blood.The blood loss was reported to be due to a leak out of the header cap.There were no adverse effects as a result of the reported complaint.

• Brand Name: HEMOCOR HPH JUNIOR HEMOCONCENTRATOR
• Common Device Name: HEMOCONCENTRATOR
• Manufacturer (Section D): MEDIVATORS INC.; 14605 28th ave n; minneapolis MN 55447
• MDR Report Key: 7891581
• Report Number: 2150060-2018-00063
• Device Sequence Number: 14075791
• Product Code: KDI
• UDI-Device Identifier: 00677964000867
• UDI-Public: 00677964000867
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K050952
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 09/19/2018

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: Other
• Device Expiration Date: 01/01/2020
• Device Model Number: HPH JUNIOR
• Device Lot Number: 762404
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/20/2018
• Initial Report FDA Received Date: 09/19/2018
• 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