BLOODTRACK, V4.9.0, 4.9.0P1, 4.9.0P2, 4.9.0P3, 4.9.0P4, 4.10.0, 4.10.1, 4.10.2 BLOODTRACK 4.9.0 - 4.10.2

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign,health professional,u report with the FDA on 2018-02-07 for BLOODTRACK, V4.9.0, 4.9.0P1, 4.9.0P2, 4.9.0P3, 4.9.0P4, 4.10.0, 4.10.1, 4.10.2 BLOODTRACK 4.9.0 - 4.10.2 manufactured by Haemonetics Corporation Software Solutions.

Event Text Entries

[99226585] Haemonetics has determined from the information which is currently available, there is no evidence that the delay in availability of the red blood cells stored in the locked kiosk contributed to the deaths of either the mother or child.
Patient Sequence No: 1, Text Type: N, H10


[99226586] On (b)(6) 2018, (b)(6) hospital, located in (b)(6) reported an incident, where emergency blood for an adult had been exhausted, due to a bleeding mother in delivery. The user required additional unit for the infant that was born during the delivery, however, the refrigerator door remained locked even though there were pediatric units available. Additionally, the kiosk screen displayed a message saying there were no emergency units available. Death did occur to the patient involved (infant) in the situation, however it is highly unlikely that the incident was the cause of death, confirmed by post mortem testing. Subsequent to this report, a defect was confirmed, which is linked to an uncommon configuration (that (b)(6) uses) that does not allow the door to be unlocked when the emergency blood for adults has been exhausted.
Patient Sequence No: 1, Text Type: D, B5


[108002643] Haemonetics has determined from the information which is currently available, there is no evidence that the delay in availability of the red blood cells stored in the locked kiosk contributed to the deaths of either the mother or child. Haemonetics has completed multiple actions to address this potential usability issue. On february 9 2018 haemonetics issued a safety alert letter to all customers utilizing the bloodtrack software version 4. 9. 0 or higher. Haemonetics also issued a technical bulletin bt-pb-18-01 during the month of february 2018, under which it was identified that haemonetics will investigate and address the root cause of the issue. Haemonetics is planning on releasing an updated version of bloodtrack software, version 4. 11 by august 31 2018 which will address the issue of preventing the availability of pediatric-sized emergency blood units.
Patient Sequence No: 1, Text Type: N, H10


[108002644] On (b)(6) 2018, (b)(6) reported an incident, where emergency blood for an adult had been exhausted, due to a bleeding mother in delivery. The user required additional unit for the infant that was born during the delivery, however the refrigerator door remained locked even though there were pediatric units available. Additionally the (b)(4) screen displayed a message saying there were no emergency units available. Death did occur to the patient involved (infant) in the situation, however it is highly unlikely that the incident was the cause of death, confirmed by post mortem testing. Subsequent to this report, a defect was confirmed, which is linked to an uncommon configuration (that south hampton uses) that does not allow the door to be unlocked when the emergency blood for adults has been exhausted.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number2951268-2018-00001
MDR Report Key7247990
Report SourceFOREIGN,HEALTH PROFESSIONAL,U
Date Received2018-02-07
Date of Report2018-05-10
Date of Event2018-01-08
Date Mfgr Received2018-01-15
Date Added to Maude2018-02-07
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 ContactMR DAVID RAMSAY
Manufacturer Street400 WOOD ROAD
Manufacturer CityBRAINTREE MA 02184
Manufacturer CountryUS
Manufacturer Postal02184
Manufacturer Phone7813487327
Manufacturer G1HAEMONETICS CORPORATION SOFTWARE SOLUTIONS
Manufacturer Street4925 ROBERT J. MATTHEWS PARKWA SUITE 100
Manufacturer CityEL DORADO HILLS CA 95762
Manufacturer CountryUS
Manufacturer Postal Code95762
Single Use3
Remedial ActionRC
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBLOODTRACK, V4.9.0, 4.9.0P1, 4.9.0P2, 4.9.0P3, 4.9.0P4, 4.10.0, 4.10.1, 4.10.2
Generic NameBLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES
Product CodeMMH
Date Received2018-02-07
Model NumberBLOODTRACK 4.9.0 - 4.10.2
OperatorNURSE
Device AvailabilityN
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerHAEMONETICS CORPORATION SOFTWARE SOLUTIONS
Manufacturer Address4925 ROBERT J. MATTHEWS PARKWA SUITE 100 EL DORADO HILLS CA 95762 US 95762


Patients

Patient NumberTreatmentOutcomeDate
101. Death 2018-02-07

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