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MAUDE Adverse Event Report

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MEDCOMP ASH SPLIT CATHETER HEMODIALYSIS CATHETER   Back to Search Results
Catalog Number ASPC28-2T
Event Date 03/31/2000
Event Type  Death   Patient Outcome  Death;
Manufacturer Narrative

On 4/14/00 an urgent product recall was initiated. No further incidents have been reported. The death may be related to inadvertent overdose. Product withdrawn for market.

 
Manufacturer Narrative

On march 31, 2000 medcomp rec'd the initial phone call from the pharmacist. Medcomp was advised on 4/3/2000 that pt recovered in surgery. On 4/4/2000 medcomp rec'd report from the sales rep that pt had expired. Following several attempts to contact hosp personnel, the risk mgr returned the call on the afternoon of 4/5/2000 and was unwilling to share info on dosage, route of administration and the pt's condition. Medcomp initiated a voluntary recall on 4/9/2000 of medcomp hemodialysis or apheresis catheters with prepackaged tricitrasol anticoagulant sodium citrate concentrate (46. 7% trisodium citrate) and the ash split cath ii hemodialysis catheter. Add'l info obtained from the medwatch form from the user facility stated the physician injected 5ml intravenously into each of the two ports. The pt suffered a cardiac arrest. Coded and moved to icu. Cacl was administered as the recommended antidote the pt, who was already in end stage renal disease, expired at 0706 on 4/1/2000.

 
Event Description

A pharmacist from the facility called for info regarding tricitrasol. Pharmacist wanted to know what it was, how it worked, and what was the antidote. The pharmacist reported that there was a pt in full cardiac arrest after an accidental overdose of sodium citrate.

 
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Brand NameASH SPLIT CATHETER
Type of DeviceHEMODIALYSIS CATHETER
Baseline Brand Name14F X 28CM ASH SPLIT CATH II W/TRICITRASOL
Baseline Generic NameHEMODIALYSIS CATHETER
Baseline Catalogue NumberASPC28-2T
Baseline Device FamilyASH SPLIT CATH II
Baseline Shelf Life Information
Is Baseline PMA Number Provided? No
Is Baseline 510(K) Number Provided? No
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Manufacturer (Section D)
MEDCOMP
1499 delp dr.
harleysville PA 19438
Manufacturer (Section G)
MEDCOMP
1499 delp drive
harleysville PA 19438
Manufacturer Contact
todd polk
1499 delp dr
harleysville , PA 19438
(215) 256 -4201
Device Event Key264677
MDR Report Key273414
Event Key256347
Report Number2518902-2000-00093
Device Sequence Number1
Product CodeMSD
Report Source Manufacturer
Source Type Health Professional,User facility
Reporter Occupation RISK MANAGER
Remedial Action Recall
Type of Report Initial,Followup
Report Date 04/07/2000,04/06/2000
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received04/10/2000
Is This An Adverse Event Report? Yes
Is This A Product Problem Report? No
Device Operator Health Professional
Device EXPIRATION Date10/01/2001
Device Catalogue NumberASPC28-2T
Device LOT NumberM001300
Was Device Available For Evaluation? No
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA04/10/2000
Distributor Facility Aware Date03/31/2000
Event Location Hospital
Date Report TO Manufacturer04/10/2000
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? No Answer Provided
Is the Device an Implant? Yes
Is this an Explanted Device? Unknown
Type of Device Usage Invalid Data

Patient TREATMENT DATA
Date Received: 04/10/2000 Patient Sequence Number: 1
#TreatmentTreatment Date
1,UNK
 
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