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.
[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
| Report Number | 2951268-2018-00001 |
| MDR Report Key | 7247990 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-07 |
| Date of Report | 2018-05-10 |
| Date of Event | 2018-01-08 |
| Date Mfgr Received | 2018-01-15 |
| Date Added to Maude | 2018-02-07 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR DAVID RAMSAY |
| Manufacturer Street | 400 WOOD ROAD |
| Manufacturer City | BRAINTREE MA 02184 |
| Manufacturer Country | US |
| Manufacturer Postal | 02184 |
| Manufacturer Phone | 7813487327 |
| Manufacturer G1 | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
| Manufacturer Street | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 |
| Manufacturer City | EL DORADO HILLS CA 95762 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 95762 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 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 |
| Generic Name | BLOOD ESTABLISHMENT COMPUTER SOFTWARE AND ACCESSORIES |
| Product Code | MMH |
| Date Received | 2018-02-07 |
| Model Number | BLOODTRACK 4.9.0 - 4.10.2 |
| Operator | NURSE |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HAEMONETICS CORPORATION SOFTWARE SOLUTIONS |
| Manufacturer Address | 4925 ROBERT J. MATTHEWS PARKWA SUITE 100 EL DORADO HILLS CA 95762 US 95762 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-07 |