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 2019-01-07 for ALARIS EXTENSION SET 20029E manufactured by Carefusion.
[132222659]
No product will be returned per customer. The customer complaint could not be confirmed because the product was not returned for failure investigation. The root cause of this failure was not identified.
Patient Sequence No: 1, Text Type: N, H10
[132222660]
The customer reported a filter leaked "at the back of the round part" and on "the side without the lines of the filter". The leak was noticed 22 hours into the tpn infusion. There was no patient harm.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2019-00010 |
| MDR Report Key | 8222036 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2019-01-07 |
| Date of Report | 2018-12-11 |
| Date of Event | 2018-12-11 |
| Date Added to Maude | 2019-01-07 |
| 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. 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 | 2019-01-07 |
| Model Number | 20029E |
| Catalog Number | 20029E |
| 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 | 2019-01-07 |