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 CT-190G CELLULOSE TRIACETATE 5M1546 manufactured by Nipro Corporation.
[1557724]
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 (b)(4) 2010 requesting contact with the nurse manager who had a clinical question. On (b)(4) 2010, 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 (b)(6) 2010, regarding the hemolysis with the two patients (b)(4) and a third incident (b)(4) with no injury. The nurse manager indicated the 2nd patient was using a ct190g reuse dialyzer, event date of (b)(6) 2010. The actual dialyzer was discarded. The facility experienced difficulty accessing the patient's fistula. The dialyzer was filled till it was pink. Issues were noted with the arterial line, adjustments were made and the patient was connected to both the arterial and venous lines of the catheter. Therapy was initiated and it was noted the venous pressure was too low at 60 and 70 for the arterial pressure. The dialyzer was noted to be clotting. The facility staff attempted to trouble shoot the issue, but ultimately set the patient up on a new machine with new bloodlines and dialyzer. The patient completed therapy and returned home. The patient went to the emergency department (ed) at 8:30 pm that night with complaints of abdominal pain. The patient was hospitalized. The patient was systematically treated and hospitalized for 4 days. The nurse manager stated the facility uses a gambro device, gambro bloodlines and minnetech renalyn reuse chemical. This is the second patient, patient b, for dialyzer issues however this patient experienced hemolysis.
Patient Sequence No: 1, Text Type: D, B5
[8654803]
(b)(4). The sample was discarded therefore no evaluation was performed.
Patient Sequence No: 1, Text Type: N, H10
[19750408]
(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. A visual inspection was performed and no obvious defects were found. 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 4 incidents were identified during the trend review. All four incidents included using gambro instruments and bloodlines.
Patient Sequence No: 1, Text Type: N, H10
[19843565]
It was reported that the pt's ins recharger was not charging. The pt stated that the black ac power ac power cord that was to be placed into the recharger did not stay plugged in. Add'l info was received that stated the pt did not meet with the physician or mfr rep regarding the event. It was also noted that the pt had surgery on (b)(6) 2010 and in (b)(6) 2010. No details were provided for these events. It was suspected that there was confusion, as the date of the pt's device implant was (b)(6) 2010. The pt was successfully reprogrammed. The pt was also able to recharge the device successfully and was no longer having problems with the device system. No further details, pt symptoms or outcome were provided at the time of this report.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1423500-2010-00922 |
| MDR Report Key | 1698585 |
| Report Source | 05,07 |
| Date Received | 2010-05-26 |
| Date of Report | 2010-05-04 |
| Date of Event | 2010-04-24 |
| Date Mfgr Received | 2010-08-10 |
| 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 | 8 7 HANUKI YACHI, NIIDA AZA |
| Manufacturer City | OHDATE SHI 0185794 |
| Manufacturer Country | JA |
| Manufacturer Postal Code | 018 5794 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CT-190G CELLULOSE TRIACETATE |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2010-05-26 |
| Catalog Number | 5M1546 |
| 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 |