MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-01-24 for DIAL MEDICAL SUPPLY B4-310 manufactured by Manufacturas Arriol C. Por A..
[14983]
One hr into pt's hemodialysis treatment, tubing began to have air in system-especially arterial chamber. Upon closeer inspection, end-user noticed air coming into tubing system at connection on arterial tubingwhere the blood pump rotates. Connection "came-apart" and was allowing air to enter. Arterial side of tubing was changed. T experienced no adverse event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1051129-1994-00015 |
| MDR Report Key | 21109 |
| Date Received | 1995-01-24 |
| Date of Report | 1994-12-28 |
| Date of Event | 1994-12-05 |
| Date Facility Aware | 1994-12-27 |
| Report Date | 1994-12-28 |
| Date Reported to FDA | 1994-12-28 |
| Date Reported to Mfgr | 1994-12-28 |
| Date Added to Maude | 1995-04-11 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DIAL MEDICAL SUPPLY |
| Generic Name | HEMODIALYSIS BLOOD TUBING |
| Product Code | FKB |
| Date Received | 1995-01-24 |
| Model Number | NA |
| Catalog Number | B4-310 |
| Lot Number | A4F08 |
| ID Number | STER. DATE JUN 94 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | * |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 27932 |
| Manufacturer | MANUFACTURAS ARRIOL C. POR A. |
| Manufacturer Address | SAN VICENTE DE PAUL ALMA ROSA Z.P. 11 SANTO DOMINGO DR |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1995-01-24 |