MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01 report with the FDA on 2004-06-02 for BERICHROM HEPARIN OWLD manufactured by Dade Behring Gmbh.
[21695870]
Pt came to hosp for dilatation of an occluded artery. Pt received a bolus of heparin. Hosp rep stated a couple hours after the heparin injection, the first blood draw was performed and recalled results to be 1. 3 - 1. 4 iu/ml, without error flags. Pt was treated over the week in an attempt to stabilize their coagulation system. The pt eventually died.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2004-00001 |
| MDR Report Key | 528321 |
| Report Source | 01 |
| Date Received | 2004-06-02 |
| Date of Report | 2004-06-01 |
| Date of Event | 2004-01-01 |
| Date Mfgr Received | 2004-05-04 |
| Date Added to Maude | 2004-06-08 |
| 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 | 0 |
| Manufacturer Contact | DONNA WOLF |
| Manufacturer Street | PO 6101, MAILSTOP 514 |
| Manufacturer City | NEWARK DE 19714 |
| Manufacturer Country | US |
| Manufacturer Postal | 19714 |
| Manufacturer Phone | 3026310384 |
| Manufacturer G1 | DADE BEHRING MARBURG GMBH |
| Manufacturer Street | 76 EMIL VON BEHRING STR |
| Manufacturer City | MARBURG |
| Manufacturer Country | GM |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BERICHROM HEPARIN |
| Generic Name | HEPARIN ASSAY |
| Product Code | KFF |
| Date Received | 2004-06-02 |
| Model Number | NA |
| Catalog Number | OWLD |
| Lot Number | UNK |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 517509 |
| Manufacturer | DADE BEHRING GMBH |
| Manufacturer Address | * MARBURG GM |
| Baseline Brand Name | BERICHROM HEPARIN |
| Baseline Generic Name | HEPARIN ASSAY |
| Baseline Model No | NA |
| Baseline Catalog No | OWLD |
| Baseline ID | NA |
| Baseline Device Family | NA |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 36 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K925200 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Death | 2004-06-02 |