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Adverse Event Report

ERIKA DE REYNOSA ARTERIAL LINE S/PILLOW NO HEP LINE BLOOD LINE   back to search results
Catalog Number 0396085
Event Type  Malfunction   Patient Outcome  Required Intervention;
Event Description

Facility alleges blood loss due to leak in the system. Report indicates approx 3 hours into treatment, blood was noted to be leaking from the arterial line at the pump segment. The line was changed and treatment resumed. Pt stable throughout. Estimated blood loss: 50cc. Per incident hematocrit: 32. 9% post 34. 4%. Facility has the sample available for investigation.

 
Manufacturer Narrative

The visual exam of the returned line showed that the pump segment had a split 8 to 9 inches from the saline tee. The damaged pump segment is untypical. The pump segment splits usually seen occur close to the point at which the pump rollers first contact the tube but this split is from the saline tee. Prssure had to be applied to the line for the split to slowly leak liquid. The pump segment had a normal abrasive wear for a ninth use line. Co consideers this complaint an isolated incident and will monitor for trends. Complaint closed.

 
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Brand NameARTERIAL LINE S/PILLOW NO HEP LINE
Type of DeviceBLOOD LINE
Baseline Brand NameARTERIAL LINE W/PILLOW NO HEPARIN LINE
Baseline Generic NameNA
Baseline Catalogue Number0396085
Baseline Device FamilyARTERIAL REUSE BLOODLINES
Baseline Device 510(K) NumberK870722
Baseline Device PMA Number
Baseline Shelf Life Information
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Date First Marketed09/14/1988
Manufacturer (Section F)
ERIKA DE REYNOSA
brecha 99 parque industria
c dreynosa
Manufacturer (Section D)
ERIKA DE REYNOSA
brecha 99 parque industria
c dreynosa
Manufacturer (Section G)
ERIKA DE REYNOSA, S.A. DE C.V.
brecha e99 sur; parque
industrial reynos, bldg. ii
cd, reynosa, tamps
MEXICO 88790
Manufacturer Contact
debra bing
2 volvo dr
rockleigh , NJ 07647
(800) 631 -1599 ext 6862
Device Event Key71242
MDR Report Key71347
Event Key67115
Report Number8030665-1997-00362
Device Sequence Number1
Product CodeFJK
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation Nurse
Type of Report Initial
Report Date 01/23/1997
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received02/21/1997
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number0396085
Device LOT NumberR6K003
OTHER Device ID Number9700018
Was Device Available For Evaluation? Yes
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Event Location Invalid Data
Date Manufacturer Received01/23/1997
Was Device Evaluated By Manufacturer? Yes
Date Device Manufactured08/01/1996
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 02/21/1997 Patient Sequence Number: 1
#TreatmentTreatment Date
1,DIALYSIS MACHINE: FRES. 2008E.,

Database last updated on January 30, 2009

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