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 2018-02-16 for MEDEX? C-FUSOR? PRESSURE INFUSOR MX4810P1 manufactured by Smiths Medical Asd, Inc..
[100315573]
(b)(6) this device is same and/or similar to a device approved for distribution in the us.
Patient Sequence No: 1, Text Type: N, H10
[100315574]
It was reported that the user of a medex? C-fusor? Pressure infusor "connected it with another commonly used device in the hospital which had led to an error". The user took the disassembled pressure bulb of the device and mistakenly attached it to a patient's infusion set. After the user connected the pressure bulb to an infusion set, the patient received an air embolism and went into cardiac arrest. The staff attempted one hour of cardiopulmonary resuscitation with no response. The patient expired.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3012307300-2018-00260 |
| MDR Report Key | 7278269 |
| Report Source | FOREIGN,HEALTH PROFESSIONAL,U |
| Date Received | 2018-02-16 |
| Date of Report | 2018-02-16 |
| Date of Event | 2017-12-15 |
| Date Mfgr Received | 2018-02-05 |
| Date Added to Maude | 2018-02-16 |
| 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 | DAVE HALVERSON |
| Manufacturer Street | 6000 NATHAN LANE NORTH |
| Manufacturer City | MINNEAPOLIS MN 55442 |
| Manufacturer Country | US |
| Manufacturer Postal | 55442 |
| Manufacturer Phone | 7633833310 |
| Manufacturer G1 | SMITHS MEDICAL INTERNATIONAL LTD |
| Manufacturer Street | 1 ST. CRISPIN WAY HASLINGDEN |
| Manufacturer City | ROSSENDALE, LANCASHIRE BB4 4PW |
| Manufacturer Country | UK |
| Manufacturer Postal Code | BB4 4PW |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MEDEX? C-FUSOR? PRESSURE INFUSOR |
| Generic Name | INFUSOR, PRESSURE, FOR I.V. BAGS |
| Product Code | KZD |
| Date Received | 2018-02-16 |
| Catalog Number | MX4810P1 |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITHS MEDICAL ASD, INC. |
| Manufacturer Address | 6000 NATHAN LANE NORTH MINNEAPOLIS MN 55442 US 55442 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2018-02-16 |