MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-09-25 for ALARIS EXTENSION SET 20028E manufactured by Carefusion.
[121860541]
No product will be returned per customer. The customer complaint could not be confirmed because the product was not returned for failure investigation. A photo received from the customer does not appear to show any leaking. The root cause of this failure was not identified.
Patient Sequence No: 1, Text Type: N, H10
[121860542]
The customer reported that an unspecified secondary chemo was programmed to infuse at a rate of 100ml/hr. When the secondary line was unclamped a leak was noted at the filter site. The chemo leaked onto the floor, however there was no report of patient, staff or family harm. The event occurred in the hematology oncology ambulatory clinic.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2018-01779 |
| MDR Report Key | 7906209 |
| Date Received | 2018-09-25 |
| Date of Report | 2018-09-04 |
| Date of Event | 2018-09-04 |
| Device Manufacturer Date | 2018-05-17 |
| Date Added to Maude | 2018-09-25 |
| 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 | 0 |
| Brand Name | ALARIS EXTENSION SET |
| Generic Name | SET, EXTENSION, INTRAVASCULAR |
| Product Code | FPB |
| Date Received | 2018-09-25 |
| Model Number | 20028E |
| Catalog Number | 20028E |
| Lot Number | 18056799 |
| 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 | 2018-09-25 |