MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,08 report with the FDA on 2014-08-04 for ABG-HM-1; HUMMI MICRO DRAW BLOOD TRANSFER DEVI manufactured by Hummingbird Med.
[5119447]
It was reported that a baxter t-connector had leaked, after being used to access arterial blood from a baby with the abg-hm-1 (hummi). The nurse stated that the baby lost 8ml of blood and required a blood transfusion due to the blood loss, since it had occurred on a low birth weight baby. The nurse mentioned that the septum had the appearance of being somewhat "pushed in. "
Patient Sequence No: 1, Text Type: D, B5
[12630668]
Hummingbird med simulation test indicates user error (not following ifu and in-service training) by inserting the hummi device inappropriately into the perimeter of the septum. Improper insertion of any blunt cannula may deform the septum and allow fluids to leak out between the septum and sidewall of the device. Direct communication with the reporting nurse at the hospital indicated the hospital has stopped using hummi product until an appropriate t-connector from another supplier is available. Contact nurse could not supply further info. The failure of the t-connector was reported by the nurse to baxter. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3009382876-2014-00001 |
| MDR Report Key | 4366749 |
| Report Source | 05,08 |
| Date Received | 2014-08-04 |
| Date of Report | 2014-08-04 |
| Date of Event | 2014-07-22 |
| Date Mfgr Received | 2014-07-25 |
| Date Added to Maude | 2014-12-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | JORGE HAIDER |
| Manufacturer Street | 2797 PRADO LN |
| Manufacturer City | MARIETTA GA 30066 |
| Manufacturer Country | US |
| Manufacturer Postal | 30066 |
| Manufacturer Phone | 7605856525 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ABG-HM-1; HUMMI MICRO DRAW BLOOD TRANSFER DEVI |
| Generic Name | SYSTEM, BLOOD COLLECTION, VACUUM-ASS |
| Product Code | KST |
| Date Received | 2014-08-04 |
| Model Number | ABG-HM-1 |
| Lot Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HUMMINGBIRD MED |
| Manufacturer Address | 2797 PRADO LN MARIETTA GA 30066 US 30066 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2014-08-04 |