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Adverse Event Report

BAXTER/SABRATEK CORP. SABRATEK 6060 HOMERUN PUMP SABRATEK 6060 PUMP   back to search results
Model Number 2M9832
Event Date 02/11/2003
Event Type  Malfunction  
Event Description

Pump did not alarm for a downstream occlusion. The pump was infusing tpn from a 2 liter bag containing 1600ml of the solution. The pump was programmed in the autoramp mode to infuse the contents of the bag over a 16 hour period. The pump is operated by the pt's parents. Infusion was started at approx 6pm and ran until 11pm when the family observed that the pt's central line was still clamped. The pump had not alarmed for the downstream occlusion and the display showed that only 80ml had been delivered. The family opened the central line and resumed the infusion without any problems and then contacted the home infusion facility's on-call nurse at approx 11:30pm to explain the event. No pt injury was reported and no medical interention was required. The nurse had a different pump sent to the family and requested they remove the current pump from service when the new pump arrives.

 
Manufacturer Narrative

Eval of this device has not been completed at the time of this report. The device has been received and a follow up report will be submitted upon completion of the eval or if any add'l details become available.

 
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Brand NameSABRATEK 6060 HOMERUN PUMP
Type of DeviceSABRATEK 6060 PUMP
Baseline Brand NameSABRATEK 6060 HOMERUN PUMP
Baseline Generic NameSABRATEK 6060 PUMP
Baseline Catalogue Number2M9832
Baseline Model Number2M9832
Baseline Device FamilySABRATEK 6060 PUMP
Baseline Device 510(K) NumberK941984
Baseline Device PMA Number
Baseline Preamendment? No
Transitional? No
510(K) Exempt? No
Shelf Life(Months)NA
Date First Marketed05/01/1995
Manufacturer (Section F)
BAXTER/SABRATEK CORP.
8111 n. st.louis ave.
skokie IL 60076
Manufacturer (Section D)
BAXTER/SABRATEK CORP.
8111 n. st.louis ave.
skokie IL 60076
Manufacturer Contact
joanne celba
route 120 & wilson road
round lake , IL 60073
(847) 270 -4696
Device Event Key438005
MDR Report Key449021
Event Key425170
Report Number6000001-2003-03490
Device Sequence Number1
Product CodeFRN
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Nurse
Type of Report Initial
Report Date 02/12/2003
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received03/11/2003
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator Health Professional
Device MODEL Number2M9832
Device Catalogue Number2M9832
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/19/2003
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/12/2003
Was Device Evaluated By Manufacturer? No
Date Device Manufactured06/01/1999
Is The Device Single Use? No
Is the Device an Implant? No
Is this an Explanted Device?
Type of Device Usage Reuse

Database last updated on February 28, 2009

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