FDA.reportPublic FDA data

MAUDE MDR 2006226

MDR report key
2006226
Report number
1225520-2011-00001
Event key
0
Event type
3
Date of event
2011-01-28
Date received
2011-02-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
2
Health professional
3
Initial report to FDA
3
Event location
0

Manufacturer Contact#

Contact
G. MURACA
Address
40 GRISSOM ROAD, SUITE 100 PLYMOUTH MA 02360 US
Phone
508-508-5087
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1HARVEST SMARTPREP2 CENTRIFUGE SYSTEM,APC-120PLATELET CONCENTRATION SYSTEMHARVEST TECHNOLOGIES CORPORATIONJQCAPC-120-0060APC-120-0060864401-0045N N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12011-02-2301. H

Event Narratives#

N

Patient 1

AN INDEPENDENT MEDICAL OPINION WAS OBTAINED ON THIS EVENT FROM (B)(4), HEMATOLOGIST. HE CONCLUDED THAT THE AUTOLOGOUS PRP PRODUCED BY UTILIZING THE HARVEST SMARTPREP2 CENTRIFUGE SYSTEM WOULD NOT BE THE CAUSE FOR THIS EVENT (OPINION ON FILE). THE PERFORMANCE OR QUALITY OF THE SMARTPREP2 CENTRIFUGE SYSTEM AND DISPOSABLE KIT WAS NOT IMPLICATED OR QUESTIONED IN THIS EVENT REPORT.

D

Patient 1

FOLLOWING TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2011, AUTOLOGOUS PLATELET RICH PLASMA (PRP) PREPARED UTILIZING THE HARVEST SMARTPREP2 SYSTEM WAS ADMINISTERED INTRA-ARTICULARLY. ON/ABOUT (B)(6) 2011, POST OPERATIVELY THE PT HAD A FEVER AND AN ELEVATED WHITE BLOOD CELL COUNT. AS PART OF THE POST-OPERATIVE ROUTINE, THE PT WAS PLACED ON ANTIBIOTIC THERAPY. POST OPERATIVE CULTURES PROVIDED NEGATIVE OR NO GROWTH RESULTS. THE HIP IMPLANT WAS REMOVED ON (B)(6) 2011. REPORT ((B)(6)) ON (B)(6) 2011 REVEALED THE PT REMAINED HOSPITALIZED, IS RECOVERING, IS STABLE, AND IS AWAITING DOCTOR'S DECISION ON REPLACEMENT HIP IMPLANT. THERE WAS NO EVIDENCE TO SUGGEST THAT THE POST OPERATIVE COMPLICATION WAS RELATED TO THE ADMINISTRATION OF THE AUTOLOGOUS PRP OR THE PERFORMANCE OF THE HARVEST SMARTPREP2 SYSTEM. REPORT ((B)(6)) ON (B)(6) 2011, PT A LOT BETTER, REMAINS HOSPITALIZED, CULTURE RESULTS SHOW NO GROWTH. PRELIMINARY DOCTOR'S MEDICAL OPINION, THINKS IS AUTOIMMUNE RESPONSE. IMPLANT STATUS NOT REPORTED. REPORT ((B)(6)) ON (B)(6) 2011, REVEALED PT IS RESPONDING TO STEROID TREATMENT & IMPROVING. NO DECISION ON WHEN TO REIMPLANT. CULTURE RESULTS NO GROWTH. REPORTS ((B)(6)) EVENT PROBABLY IS NOT RELATED TO PRP.