CA-HP 5M2733

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05 report with the FDA on 2011-06-22 for CA-HP 5M2733 manufactured by Nipro Corporation *usd*.

Event Text Entries

[17197116] A customer reported to baxter (b)(4) that five units of cahp-130 dialyzer were noted leak or blood leak with alarm only after two or three times of reprocessing, which much less normal reuse times (normal reuse 10 times).
Patient Sequence No: 1, Text Type: D, B5


[17313728] (b)(4). The sample was received and evaluated. Upon visual inspection no obvious defects were found. Then performed manual leak test and observed pressure decay of greater than 10 mmhg per 60 seconds. Further testing was done with manual bubble point test per same sop. Pressure dropped to zero and bubbles were sighted at the venous header and coming out of the dialysate port. This confirms the complaint. 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 letter chi-07-10.
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1423500-2011-07999
MDR Report Key2136792
Report Source01,05
Date Received2011-06-22
Date of Report2008-12-10
Date of Event2008-12-10
Date Mfgr Received2009-01-28
Date Added to Maude2012-02-13
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactKAREN KIRBY
Manufacturer Street25212 W. ILLINOIS ROUTE 120
Manufacturer CityROUND LAKE IL 60073
Manufacturer CountryUS
Manufacturer Postal60073
Manufacturer Phone8472704541
Manufacturer G1NIPRO CORPORATION *USD*
Manufacturer CountryJA
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameCA-HP
Generic NameHEMODIALYZER, RE-USE, HIGH FLUX
Product CodeMSF
Date Received2011-06-22
Returned To Mfg2009-01-06
Catalog Number5M2733
Lot Number08B25B
Device Expiration Date2011-01-31
OperatorHEALTH PROFESSIONAL
Device AvailabilityR
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerNIPRO CORPORATION *USD*
Manufacturer AddressJA


Patients

Patient NumberTreatmentOutcomeDate
10 2011-06-22

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