MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,07 report with the FDA on 2004-12-21 for CARMEDA PEDIATRIC BIO-PROBE CBDP-38P 1133012-501 manufactured by Medtronic Perfusion Systems.
[534344]
Information received indicates that unit cracked and leaked during the case after three days service life. The product was changed-out of the circuit with no effect, other than minimal blood loss reported for the patient.
Patient Sequence No: 1, Text Type: D, B5
[7987108]
Returned product inspection confirms the reason for return; a large-crack is seen, and a leak noted, in the probe body located at the connector port. A discoloration of the plastic (acrylic) material is evidence that a non-compatible substance came in contact with the device. This substance attacked (weakened) the plastic at the port making it susceptible to fracture. Event information shows the amount of blood loss reported was 150ml and the patient received transfusion of blood products when blood pressure dropped temporarily. No other patient event reported. Review of the device history record shows the device met manufacturing specifications for product released to distribution. No subsequent patient complication. User error contributed to the reported product problem.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2184009-2004-00119 |
| MDR Report Key | 778134 |
| Report Source | 01,05,07 |
| Date Received | 2004-12-21 |
| Date of Report | 2004-11-22 |
| Date of Event | 2004-11-22 |
| Date Facility Aware | 2004-11-22 |
| Report Date | 2004-11-22 |
| Date Reported to Mfgr | 2004-11-22 |
| Date Mfgr Received | 2004-11-22 |
| Device Manufacturer Date | 2004-05-01 |
| Date Added to Maude | 2006-11-09 |
| 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 | LISA WEIK |
| Manufacturer Street | 8299 CENTRAL AVE NE |
| Manufacturer City | MINNEAPOLIS MN 55432 |
| Manufacturer Country | US |
| Manufacturer Postal | 55432 |
| Manufacturer Phone | 7635146694 |
| Manufacturer G1 | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Street | 7611 NORTHLAND DRIVE |
| Manufacturer City | BROOKLYN PARK MN 55428 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 55428 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CARMEDA PEDIATRIC BIO-PROBE |
| Generic Name | EXTRAVASCULAR BLOOD FLOW PROBE |
| Product Code | DPT |
| Date Received | 2004-12-21 |
| Returned To Mfg | 2004-12-03 |
| Model Number | CBDP-38P |
| Catalog Number | 1133012-501 |
| Lot Number | 0406001417 |
| ID Number | NA |
| Device Expiration Date | 2006-05-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | 3 DAY |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 765908 |
| Manufacturer | MEDTRONIC PERFUSION SYSTEMS |
| Manufacturer Address | 7611 NORTHLAND DR. MINNEAPOLIS MN 55428 US |
| Baseline Brand Name | CARMEDA PEDIATRIC BIO-PROBE |
| Baseline Generic Name | EXTRAVASCULAR BLOOD PLOW PROBE |
| Baseline Model No | CBDP-38P |
| Baseline Device Family | FLOW PROBE |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 24 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K891687 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2004-12-21 |