HARVEST TERUMO 51423

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-06-23 for HARVEST TERUMO 51423 manufactured by Terumo Bct.

Event Text Entries

[78520496] Additional product code: fmf. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[78520497] Upon review of the information provided by the distributor, it was discovered that an expired bone marrow aspirate concentrate (bmac) disposable was used on a patient. The bmac disposable set was labeled with an expiration date of 04/01/2017. The blood was processed and the bmac product was administered to the patient on (b)(6) 2017. Patient? S age, gender, and weight are not available at this time. Patient outcome is not available at this time. The bmac set is not available for return because it was discarded by the customer.
Patient Sequence No: 1, Text Type: D, B5


[119218254] Investigation: the harvest disposable set was unavailable for return and investigation. The harvest disposable set contain multiple components that have various expiry dates. The outer set label contains the expiry date associated with the component that has the shortest expiry timeframe. Based on the information stated on the shipping slip, the use of an expired set was confirmed. Investigation is in process. A follow-up report will be provided.
Patient Sequence No: 1, Text Type: N, H10


[119218255] The customer declined to provide patient's age, gender, weight and outcome.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1722028-2017-00245
MDR Report Key6663299
Date Received2017-06-23
Date of Report2017-06-23
Date of Event2017-05-01
Date Mfgr Received2018-04-23
Device Manufacturer Date2015-11-17
Date Added to Maude2017-06-23
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactSTEVE KERN
Manufacturer Street10810 W. COLLINS AVE.
Manufacturer CityLAKEWOOD CO 80215
Manufacturer CountryUS
Manufacturer Postal80215
Manufacturer Phone3032392246
Single Use3
Previous Use Code3
Event Type3
Type of Report0

Device Details

Brand NameHARVEST TERUMO
Generic NameBMAC2 120-01, BONE MARROW ASPIRATE CONCENTRATE PROCEDU
Product CodeJQC
Date Received2017-06-23
Catalog Number51423
Lot Number11Y9905
Device Expiration Date2017-04-01
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerTERUMO BCT
Manufacturer AddressLAKEWOOD CO 80215 US 80215


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2017-06-23

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