MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 1999-07-23 for NEPHRETECT 5000 manufactured by Alden Scientific, Inc..
[159724]
Dialysis was to be performed prior to dialysis, the dialysate was tested for formaldehyde, using nephretect. The test was performed once, per clinic procedure. The result was negative and dialysis began. Patient immediately complained of discomfort, and numbness in extremities. Dialysis was haulted and the dialysis machine was promptly refrigerated. 07/20/99: dialysate from that machine was tested, again using nephretect and the results were positive in three of three trials. It is unclear as to the temperature of the dialysate analyzed on this date. 07/21/99: nurse telephoned alden and was asking if the temprature of the dialysate tested on 07/20/99 could have caused the test to produce false positive results on that day. Co responded that a temprature higher than 37 degrees c can cause false positive results, but did not offer any data concerning solutions below 37 degrees c. Samples of the dialysate are unavailable for analysis by alden. Normal testing done by alden on the nephretect lot #09219 showed it met all specifications. Co telephoned dialysis clinic and in discussing the incident with the clinical nurse, it is believed that the rising procedure was not completely followed. Co discussed, in detail, the correct rising procedure and had some minor changes made for the clinic. The conclusion is that improper rinsing procedures, prior to the device use, cause the disinfectant(formaldehyde) "rebound syndrome".
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1221361-1999-00001 |
| MDR Report Key | 233339 |
| Report Source | 06 |
| Date Received | 1999-07-23 |
| Date of Report | 1999-07-21 |
| Date of Event | 1999-07-19 |
| Date Mfgr Received | 1999-07-21 |
| Device Manufacturer Date | 1999-02-01 |
| Date Added to Maude | 1999-07-29 |
| 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 | 0 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | NEPHRETECT |
| Generic Name | FORMALDEHYDE DETECTOR |
| Product Code | HZT |
| Date Received | 1999-07-23 |
| Model Number | NA |
| Catalog Number | 5000 |
| Lot Number | 09219 |
| ID Number | * |
| Device Expiration Date | 2000-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 226178 |
| Manufacturer | ALDEN SCIENTIFIC, INC. |
| Manufacturer Address | 360 COLD SPRING AVE. WEST SPRINGFIELD MA 01089 US |
| Baseline Brand Name | NEPHRETECT |
| Baseline Generic Name | FORMALDEHYDE TEST REAGENT |
| Baseline Model No | UNK |
| Baseline Catalog No | 5000 |
| Baseline ID | NA |
| Baseline Device Family | CHEMICAL INDICATOR |
| Baseline Shelf Life Contained | Y |
| Baseline Shelf Life [Months] | 18 |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K934066 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1999-07-23 |