MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional report with the FDA on 2018-12-26 for ALARIS EXTENSION SET 20029E manufactured by Carefusion.
[131591523]
Although requested, the affected product has not been received. A follow up report will be submitted with investigation results should the devices be received for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[131591524]
The customer reported a filter leaked. There was no report of patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2018-02606 |
| MDR Report Key | 8197867 |
| Report Source | HEALTH PROFESSIONAL |
| Date Received | 2018-12-26 |
| Date of Report | 2018-12-06 |
| Date Added to Maude | 2018-12-26 |
| 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. ADE AJIBADE |
| 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 EXTENSION SET |
| Generic Name | SET, EXTENSION, INTRAVASCULAR |
| Product Code | FPB |
| Date Received | 2018-12-26 |
| Returned To Mfg | 2019-01-02 |
| Model Number | 20029E |
| Catalog Number | 20029E |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2018-12-26 |