MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2010-05-26 for CAHP-210 CELLULOSE DIACETATE DIALYZER 5M2736 manufactured by Nipro Corporation.
[1401910]
Initially, the complaint originated as a result of the baxter renal clinical helpline representative (brcr) receiving a voice mail message from the baxter sales representative (bsr) account manager on 4-29-10 requesting contact with the nurse manager who had a clinical question. On 5-4-10, product surveillance placed a follow up call to the nurse manager regarding the incidences and the related complaints. The nurse manager stated she spoke with the bsr on 5-4-10 regarding the hemolysis with the two patients (b)(4) and a third incident (b)(4) with no injury. The nurse manager stated that the first patient was using a ca-hp210 reuse dialyzer with an event date of (b)(6) 2010. The actual dialyzer was discarded. The patient was on coumadin. The patient stated he had noted a 2 gram drop in hemoglobin thursday prior to the event. The day of treatment, the hemodialysis needles were placed, an issue was noted with the arterial needle, the dialyzer was prepared, and it was then noted the arterial venous pressure was inappropriate for the pressures set. The dialyzer was clotting. The staff attempted to a reset up with a new dialyzer and new bloodlines. The patient was able to complete treatment. The patient then went to the bathroom and noted blood in his urine. The patient was sent to the emergency department (ed) and was admitted to the hospital. The oncologist diagnosed thrombotic thrombocytopenia purpura (ttp). The patient underwent plasmapheresis treatment for the ttp and was started on steroids. The patient hospitalized for five days. Reportedly, facility considered the root cause analysis was related to the underlying (ttp) and lupus, but the hemolysis may have been caused by the dialysis. The nurse manager stated that the patient likely did not get his full dose of heparin as the loading dose and hourly dose were delayed because of the setup issue with the therapy. This is the first patient, patient a, for dialyzer issues and this patient experienced hemolysis.
Patient Sequence No: 1, Text Type: D, B5
[1527536]
It was reported pt's "hose came loose and she had to go in and have surgery to have it fixed". At the time of this report, no further info was reported. Additional info will be provided when available.
Patient Sequence No: 1, Text Type: D, B5
[8632014]
(b)(4). The sample was not returned therefore no evaluation was performed.
Patient Sequence No: 1, Text Type: N, H10
[8777027]
(b)(4). The manufacturer, nipro, performed a batch review and retention sample review on the lot number of the product. No abnormality was found in the records or findings of the biological tests performed in the release inspection of the lots involved. No abnormality was found in the findings of the biological tests performed for the retained samples. A companion sample was received and evaluated. The lot number had been rubbed off the label on the dialyzer. A visual inspection was performed and no obvious defects were found except for the lot number. A bubble point leak test was performed for any leakage and there were no bubbles present and no leakage could be found. A trend review was performed and no adverse trend was associated with hemolysis and nipro's cellulosic and synthetic fibered dialyzers. Only four incidents were identified during the trend review. All four incidents included using gambro instruments and bloodlines.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2010-00924 |
| MDR Report Key | 1699110 |
| Report Source | 05,07 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-04 |
| Date of Event | 2010-03-27 |
| Date Mfgr Received | 2010-08-11 |
| Date Added to Maude | 2010-08-18 |
| 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 | KAREN KIRBY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472704541 |
| Manufacturer G1 | NIPRO CORPORATION |
| Manufacturer Street | 87 HANUKI YACHI, NIIDA AZA |
| Manufacturer City | OHDATE SHI 0185794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 0185794 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAHP-210 CELLULOSE DIACETATE DIALYZER |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2010-05-26 |
| Catalog Number | 5M2736 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO CORPORATION |
| Manufacturer Address | 8 7 HANUKI YACHI, NIIDA AZA OHDATE SHI 0185794 JA 0185794 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 2010-05-26 |