MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2000-06-07 for DP-38, BIO-PROBE DISPOSABLE INSERT 95133 manufactured by Medtronic Cardiopulmonary.
[166947]
The hosp reported that the dp-38 insert leaked after seven hours, a tear was seen. The unit was changed out with no effect to the pt.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2184009-2000-00038 |
| MDR Report Key | 281563 |
| Report Source | 01,05,06,07 |
| Date Received | 2000-06-07 |
| Date of Report | 2000-06-06 |
| Date Facility Aware | 2000-05-08 |
| Report Date | 2000-06-06 |
| Date Mfgr Received | 2000-05-08 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 2000-06-15 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Street | 7611 NORTHLAND DR |
| Manufacturer City | MINNEAPOLIS MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal | 55428 |
| Manufacturer Phone | 7633919073 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | DP-38, BIO-PROBE DISPOSABLE INSERT |
| Generic Name | PROBE, BLOOD FLOW, EXTRACOPOREAL |
| Product Code | DPT |
| Date Received | 2000-06-07 |
| Model Number | DP-38 |
| Catalog Number | 95133 |
| Lot Number | 9902002188 |
| ID Number | NA |
| Device Expiration Date | 2004-02-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1.4 YR |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 272483 |
| Manufacturer | MEDTRONIC CARDIOPULMONARY |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Baseline Brand Name | BIO-MEDICUS FLOW PROBE, ADULT |
| Baseline Generic Name | FLOW PROBE |
| Baseline Model No | DP-38 |
| Baseline Device Family | BIO-PROBES |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K830858 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2000-06-07 |