D
Patient 1
PT REACTION DURING TREATMENT. SYMPTOMS: EXTREME TACHYCARDIA. RELIEVED WITH O2 AT 2 L/MIN. DIALYZER TYPE CHANGED AND TREATMENT RESUMED. NO INJURY.
MAUDE MDR 159488
- MDR report key
- 159488
- Report number
- 8030992-1998-00001
- Event key
- 0
- Event type
- 3
- Date of event
- 1998-02-13
- Date received
- 1998-03-27
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 0
Manufacturer Contact#
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LUNDIA ALPHA 700 | PLATE DIALYZER | GAMBRO HEALTHCARE | FJG | NA | NO1B49004 | 7-0014-L01 | N | R | N |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 1998-03-27 | 0 | 1. O |
Event Narratives#
N
Patient 1
EVENT DESCRIPTION: PT REACTION DURING TREATMENT. SYMPTOMS WERE: DYSPNEA FLUSHING., SHORT BREATH, HYPOTENSIVE AND CHEST TIGHTNESS, BENADRYL GIVEN AND TREATMENT DISCONTINUED. TREATMENTS RESUMED WITH DIFFERENT TYPE OF DIALYZER. INVESTIGATION / DETERMINATION OF CAUSE: THE REVIEW OF DEVICE HISTORY RECORDS DOES NOT INDICATE ANY DEVIATIONS DURING PRODUCTION OF THE LOT. THE PT COULD HAVE DEMONSTRATED A HYPERSENSITIVITY HISTORY TO A VARIETY OF SUBSTANCES INCLUDING PRODUCTS STERILIZED WITH "ETO." THE PT HAD NOT BEEN ON DIALYSIS VERY LONG. SAFETY ANALYSIS: USERS ARE ADVISED OF THE POSSIBILITY OF ADVERSE REACTION IN THE INSTRUCTION FOR USE: EXTRA CARE MUST BE TAKEN WHEN TREATING PTS FOR THE FIRST THREE TO FOUR WEEKS WITH A SPECIFIC DIALYZER, OR PTS WHO HAVE EXHIBITED POSSIBLE HYPERSENSITIVITY TO PRODUCTS STERILIZED WITH ETHYLENE OXIDE, OR PTS WHO HAVE A HISTORY OF BEING HIGHLY SENSITIVE AND ALLERGIC TO A VARIETY OF SUBSTANCES. (IFU NO 1892) SAME LOT SAMPLES WERE ANALYZED FOR RESIDUALS. THE RESULTS WERE NOT QUANTIFIABLE. FOLLOW-UP ACTION THE POSSIBILITY OF PT REACTION DUE TO THE COMPLEX INTERACTION BETWEEN BLOOD AND THE ARTIFICIAL SURFACE OF THE ENTIRE EXTRACORPOREAL CIRCUIT IS DESCRIBED. THESE REACTIONS MAY ALSO BE EXACERBATED BY OTHER EXTERNAL FACTORS INVOLVED WITH THE INDIVIDUAL PTS SPECIFIC DISEASE PROCESS AND THE TREATMENT OF RENAL INSUFFICIENCY. THE EXACT CAUSE OF THE REPORTED EVENT IS UNKNOWN. DHR REVIEW REVIEW OF THE DEVICE HISTORY RECORD DOES NOT INDICATE ANY DEVIATION OF DURING PRODUCT OF THE LOT. NO OTHER REACTIONS COMPLAINTS HAVE BEEN FILED AGAINST THIS LOT NUMBER.