FDA.reportPublic FDA data

MAUDE MDR 506556

MDR report key
506556
Report number
1225520-2003-00013
Event key
0
Event type
3
Date of event
2003-12-05
Date received
2003-12-19
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
DON KEREN
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 (DISPOSABLE)PRP SYSTEM DISPOSABLEHARVEST TECHNOLOGIESJQCAPC-60APC-60PR60-0015K000037NYR

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12003-12-190

Event Narratives#

D

Patient 1

THERE WAS A REPORT OF BLOOD SPILLAGE FROM A FS-60 DISPOSABLE. THE INSTRUMENT AND DISPOSABLE WERE RETURNED AND EVALUATED. THE INSTRUMENT HAD A LARGE AMOUNT OF BLOOD SPILLED IN IT CONSISTENT WITH THE REPORTED COMPLAINT. UPON CLEANING THE INSTRUMENT PASSED ALL NECESSARY QUALITY CRITERIA. THE DISPOSABLE WAS EXAMINED AND IT WAS OBVIOUSLY BROKEN AT THE BLOOD TUBE APPROXIMATELY HALF WAY DOWN. THE BOTTOM SECTION OF THE BLOOD TUBE WAS SHATTERED DUE TO BECOMING DISLODGED WITHIN THE CENTRIFUGE WHILE IT WAS RUNNING. THE DISPOSABLE WAS ALSO DEFORMED ON THE RIB IN AN AREA ADJACENT TO THE LOCATING TAB ON THE TRUNNION WHICH DETERMINES THE CORRECT SEATING FOR THE DISPOSABLE DURING CENTRIFUGATION. THIS DEFORMATION INDICATES THAT THE DISPOSABLE WAS SEATED CORRECTLY DURING CENTRIFUGATION. A DISPOSABLE FROM A SIMILAR LOT WAS SEATED ON A TRUNION IN THE SAME MANNER AND CENTRIFUGED AND AN INDENTICAL FAILURE OCCURRED. HARVEST HAS INSTITUTED CHANGES IN THE TRUNION DESIGN THAT WOULD INCREASE EASE OF USE FOR THE OPERATOR, HOWEVER, THE USER INSTRUCTIONS ARE QUITE CLEAR ON THE USR OF THE DEVICE IN THIS ASPECT. THERE WAS NO PATIENT INJURY INVOLVED IN THIS INCIDENT.