MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 04,05 report with the FDA on 2011-06-20 for CA-HP 5M2736 manufactured by Nipro Corporation *usd*.
[16410416]
This complaint originated as a result of baxter product surveillance receiving a voicemail from baxter corporate mailbox stating a customer had a dialyzer that had a blood leak. The customer reported a dialyzer that had a blood leak at another clinic. The customer stated it was a baxter dialyzer (b)(4), lot 8g16e. It was unknown where the blood leak was from. The blood leak was discovered by a blood leak alarm and a pressure alarm on the machine and then the facility tested the dialyzer. The blood leak was confirmed by a hemastix test. No other types of strips were used. The test strips were used by fluid poured into the cap and tested. The customer could not estimate blood loss to the patient because the dialyzer was still full of blood. They did not return the blood to the patient. There was no patient injury, medical intervention or hospitalization as a result of this incident. The patient resumed therapy with a new dialyzer. This is a reusable dialyzer and this incident is the eighth reuse of this dialyzer. The dialyzer was preprocessed beforehand but not afterwards. The facility uses an automated renatron machine. The incoming static was 38 and dynamic water pressure was 30. The chemical agent used was renalyn. The customer stated she thought the dialyzer passed the leak test prior to patient use because they started treatment. The dialyzer was pre-rinsed before placing on the reuse device. The average reuse number with these dialyzers was about 14. The customer still has the dialyzer. Product surveillance spoke to the re-use technician and obtained the following additional information. The blood leak occurred at the onset of treatment, less than 1 minute after starting the treatment. The customer was unsure if the pressure alarm was "arterial, venous or transmembrane pressure. " the estimated blood loss to the patient was 200-250ml. This occurred with a fresenius 2008k hemodialysis machine. A sample return kit will be sent to the customer.
Patient Sequence No: 1, Text Type: D, B5
[16569297]
(b)(4). The sample was received and evaluated. Disinfection procedure was performed but all the blood was unable to be removed from the dialyzer. A visual inspection was performed and no other obvious defects were found. There was blood clots in the venous header and blood still left in the dialyzer. The reported problem could not be confirmed and the root cause could not be determined. Baxter has conducted a trend review and found that similar reports have been received for the reported problem. Baxter will continue to monitor similar reports to determine if further actions are required. A batch review was conducted and no issues were found related to the reported condition during the manufacture of the lot. This mdr is being submitted as part of baxter renal's retrospective review & remediation project. This report is being filed late to fulfill baxter's commitment to perform a two year retrospective review of renal complaints in response to fda-warning (b)(6).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1423500-2011-07976 |
| MDR Report Key | 2134688 |
| Report Source | 04,05 |
| Date Received | 2011-06-20 |
| Date of Report | 2009-06-01 |
| Date of Event | 2009-05-29 |
| Date Mfgr Received | 2009-06-01 |
| Date Added to Maude | 2011-10-27 |
| 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 | 0 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | VIRGINIA MCKINNEY |
| Manufacturer Street | 25212 W. ILLINOIS ROUTE 120 |
| Manufacturer City | ROUND LAKE IL 60073 |
| Manufacturer Country | US |
| Manufacturer Postal | 60073 |
| Manufacturer Phone | 8472702835 |
| Manufacturer G1 | NIPRO CORPORATION USD |
| Manufacturer Street | 8-7 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 | CA-HP |
| Generic Name | HEMODIALYZER, RE-USE, HIGH FLUX |
| Product Code | MSF |
| Date Received | 2011-06-20 |
| Returned To Mfg | 2009-06-11 |
| Catalog Number | 5M2736 |
| Lot Number | 08G16E |
| Device Expiration Date | 2011-06-30 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | NIPRO CORPORATION *USD* |
| Manufacturer Address | 8-7 HANUKI-YACHI, NIIDA-AZA OHDATE-SHI 0185794 JA 0185794 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-06-20 |