MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,health report with the FDA on 2020-03-28 for ALARIS? PUMP MODULE ADMINISTRATION SET 2426-0007 manufactured by Carefusion.
[188263648]
Although requested, device has not been received. A follow up report will be submitted with failure investigation results should the device be received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[188263649]
It was reported that the tubing separated while the bag was being changed. There was no patient injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2020-01145 |
| MDR Report Key | 9892648 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-05 |
| Date of Event | 2020-02-18 |
| Device Manufacturer Date | 2019-10-01 |
| Date Added to Maude | 2020-03-28 |
| 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. MUSTAFA OMAR |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal | 921214386 |
| Manufacturer Phone | 8586172000 |
| Manufacturer G1 | CAREFUSION |
| Manufacturer Street | 10020 PACIFIC MESA BLVD |
| Manufacturer City | SAN DIEGO CA 921214386 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 921214386 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALARIS? PUMP MODULE ADMINISTRATION SET |
| Generic Name | SET,ADMINISTRATION,INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-28 |
| Model Number | 2426-0007 |
| Catalog Number | 2426-0007 |
| Lot Number | 19105084 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CAREFUSION |
| Manufacturer Address | 10020 PACIFIC MESA BLVD SAN DIEGO CA 921214386 US 921214386 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-28 |