MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-21 for PROSORBA COLUMN 9798701 manufactured by Fresenius Hemocare.
[17442095]
Pt became dizzy and bp low during 5th prosorba treatment. Pt then developed some chest pain so treatment was discontinued. Pt had complex cardiac history and recently discontinued use of ace inhibitor. Pt was admitted to the hosp for evaluation and diagnosis reached was that pt had pneumonia. Antibiotics were administered and pt was discharged. In 09/2005 co received confirmation that pt had a cardiac consult at which it was determined that pt could not continue prosorba treatment. Pt has continued treatments and tolerated them well with premed of 80 mg solumedrol and using heparin instead of acid citrate dextose (acd) as anticoagulant. Pt also receives a ns bolus at the start treatment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3032792-2005-00017 |
| MDR Report Key | 636644 |
| Report Source | 05 |
| Date Received | 2005-09-21 |
| Date of Report | 2005-09-21 |
| Date of Event | 2005-08-01 |
| Report Date | 2005-09-21 |
| Date Mfgr Received | 2005-08-01 |
| Device Manufacturer Date | 2005-01-01 |
| Date Added to Maude | 2005-09-26 |
| 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 | JOE WINSLOW |
| Manufacturer Street | 14715 NE 95TH ST, STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal | 98052 |
| Manufacturer Phone | 7814029319 |
| Manufacturer G1 | FRESENIUS HEMOCARE |
| Manufacturer Street | 14715 NE 95TH ST, STE 100 |
| Manufacturer City | REDMOND WA 98052 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 98052 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PROSORBA COLUMN |
| Generic Name | PROTEIN A IMMUNOADSORPTION COLUMN |
| Product Code | LQQ |
| Date Received | 2005-09-21 |
| Model Number | 9798701 |
| Catalog Number | 9798701 |
| Lot Number | RAN002C |
| ID Number | NA |
| Device Expiration Date | 2006-07-31 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 7 MO |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 626172 |
| Manufacturer | FRESENIUS HEMOCARE |
| Manufacturer Address | * REDMOND WA * US |
| Baseline Brand Name | PROSORBA COLUMN |
| Baseline Generic Name | THERAPEUTIC PLASMA EXCHA |
| Baseline Catalog No | 9798701 |
| Baseline Device Family | PROTEIN A IMMUNOADSORPTION COL |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 12 |
| Baseline PMA Flag | Y |
| Premarket Approval | P8500 |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 2005-09-21 |