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 PCA MODULE SET 10800175 manufactured by Carefusion.
[188263307]
The devices have been received and the evaluation is pending. A follow up report will be submitted with investigation results once the evaluation has been completed. Additional information requested, but was not received.
Patient Sequence No: 1, Text Type: N, H10
[188263308]
It was reported that the pca tubing set is cracked.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9616066-2020-01134 |
| MDR Report Key | 9892639 |
| Report Source | COMPANY REPRESENTATIVE,HEALTH |
| Date Received | 2020-03-28 |
| Date of Report | 2020-03-05 |
| Device Manufacturer Date | 2019-09-12 |
| 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 |
| Reporter Occupation | PHARMACIST |
| 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 PCA MODULE SET |
| Generic Name | SET,ADMINISTRATION,INTRAVASCULAR |
| Product Code | FPA |
| Date Received | 2020-03-28 |
| Returned To Mfg | 2020-03-19 |
| Model Number | 10800175 |
| Catalog Number | 10800175 |
| Lot Number | 19095871 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| 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 |