MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2008-06-06 for STERICHEK SENSITIVE TOTAL CHLORAMINES AND RESIDUAL CHLORINE REAGENT STRIPS 811909 manufactured by Hach Company.
[21961920]
Thirty-two (32) pts involved. In 2008, a dialysis facility nurse reviewing routine weekly lab results for the facility's dialysis pts noted a drop in hemoglobin for 32 patients. The facility alleges that hach test strips used to detect chlorine had given false negative readings. Thirty-one of the thirty-two pts were reportedly diagnosed with anemia. One pt was reportedly diagnosed with hemolytic anemia and myocardial infarction.
Patient Sequence No: 1, Text Type: D, B5
[21989027]
Add'l lot#: 7163. Add'l device manufacture date: 06/2007. Results: sample retains from both lots have been tested for chlorine and chloramines. Both lots passed the chlorine test at all concentrations, and passed the chloramines at concentrations 0. 0 ppm, 0. 1 ppm, and 0. 5 ppm. Applies to lot #7044 only. Test strips from lot #7044 may detect a lower concentration of chloramines at the 1. 0 ppm concentration. Conclusions: in accordance with the aami standard, the maximum allowable chloramines level in water used to prepare dialysate is a concentration of 0. 1 ppm (mg/l). Reagent strips from both lots therefore properly detect the maximum allowable chloramines levels as directed by the aami standard. Furthermore, the directions for use for the sterichek sensitive feed water and rinse water reagent strips states the following: feed water: a result of greater than 0. 1 ppm indicates that the feed water tested should not be used to prepare dialysate, and the carbon absorption media used to remove excess levels of chloramines may need to be replaced. Rinse water: a result of greater than 0. 5 ppm indicates that an add'l rinse cycle should be performed on the machine. Therefore, there is a margin of safety built into the reagent strips should the reagent strips detect a lower concentration of chloramines at 1. 0 ppm or above.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1833407-2008-00001 |
| MDR Report Key | 1057444 |
| Report Source | 05,06 |
| Date Received | 2008-06-06 |
| Date of Report | 2008-05-15 |
| Date of Event | 2008-04-30 |
| Date Mfgr Received | 2008-05-15 |
| Device Manufacturer Date | 2007-02-01 |
| Date Added to Maude | 2008-06-12 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | DIANE DRAPER, MANAGER |
| Manufacturer Street | 100 DAYTON AVE. |
| Manufacturer City | AMES IA 50010 |
| Manufacturer Country | US |
| Manufacturer Postal | 50010 |
| Manufacturer Phone | 5152322533 |
| Single Use | 3 |
| Remedial Action | RC |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STERICHEK SENSITIVE TOTAL CHLORAMINES AND RESIDUAL CHLORINE REAGENT STRIPS |
| Generic Name | SYSTEM, DIALYSATE DELIVERY, SINGLE PATIENT |
| Product Code | MSY |
| Date Received | 2008-06-06 |
| Catalog Number | 811909 |
| Lot Number | 7044 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 1025627 |
| Manufacturer | HACH COMPANY |
| Manufacturer Address | AMES IA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2008-06-06 |