FDA.reportPublic FDA data

MAUDE MDR 7293824

MDR report key
7293824
Report number
0001825034-2018-01395
Event key
0
Event type
3
Date of event
2018-01-23
Date received
2018-02-23
Adverse event
3
Product problem
3
Patients in event
0
Reporter occupation
0
Health professional
3
Initial report to FDA
3
Event location
3

Manufacturer Contact#

Contact
MS. CHRISTINA ARNT
Address
56 E. BELL DR. WARSAW IN 46582 US
Phone
574-574-5745
Report source
M
Manufacturer link flag
Y

Devices#

Seq, Brand, Generic table
SeqBrandGenericManufacturerProduct codeModelCatalogLotPMA510(k)ImplantEvaluatedAvailability
1GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEMSUPPLIES, BLOOD-BANKZIMMER BIOMET, INC.KSSN/A800-1006A700931R N

Patients#

Sequence, Received, Treatment table
SequenceReceivedTreatmentOutcome
12018-02-2301. O

Event Narratives#

N

Patient 1

(B)(4). CONCOMITANT MEDICAL PRODUCTS: UNKNOWN PART#, GPS III GRAVITATIONAL PLATELET SEPARATION SYSTEM, LOT 700931, QUANTITY 2. PATIENT WAS STUCK WITH NEEDLE ADDITIONAL TIMES. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. NOT RETURNED TO MANUFACTURER.

D

Patient 1

IT WAS REPORTED THAT WHEN THE PATIENT?S BLOOD WAS DRAWN INTO THE TUBE AND PLACED INTO CENTRIFUGE, THE COMPARTMENTS ON THE TUBE LEAKED AND DID NOT SEPARATE THE SPECIMEN PROPERLY. PATIENT?S BLOOD SPECIMEN WAS NOT VIABLE. PATIENT?S BLOOD WAS TAKEN AGAIN AND PLACED IN ANOTHER TUBE. ONCE THE BLOOD ENTERED THE TUBE THE COMPARTMENTS BEGAN TO LEAK AGAIN. THE BLOOD WAS THEN DRAWN FROM THE TUBE AND PLACED INTO ANOTHER TUBE FROM ANOTHER LOT NUMBER, WHERE PROCESSING WAS COMPLETE. NO FURTHER INFORMATION HAS BEEN MADE AVAILABLE AT THIS TIME.