N
Patient 1
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.
MAUDE MDR 7247990
- MDR report key
- 7247990
- Report number
- 2951268-2018-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 2018-01-08
- Date received
- 2018-02-07
- 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
- MR DAVID RAMSAY
- Address
- 400 WOOD ROAD BRAINTREE MA 02184 US
- Phone
- 781-781-7813
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | 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 | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS | MMH | BLOODTRACK 4.9.0 - 4.10.2 | Y | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2018-02-07 | 0 | 1. D |
Event Narratives#
D
Patient 1
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.
N
Patient 1
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.
D
Patient 1
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.