FDA Adverse Event Malfunction Summary report: N

ALARIS SYRINGE MODULE

MDR report key: 2251687 · Received August 31, 2011

Report

Report Number: 2016493-2011-00490
Event Type: Malfunction
Date Received: August 31, 2011
Date of Event: August 12, 2011
Report Date: August 16, 2011
Manufacturer: CAREFUSION CORP.
Product Code: FRN
PMA / PMN Number: K023264
Removal / Correction Number: NA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: AL, US
Reporter Occupation: BIOMEDICAL ENGINEER

Narratives

Additional Manufacturer Narrative · 1

(B)(4). LOGS RECEIVED AND LOG REVIEW PENDING. THE DEVICE LOGS HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE EVAL IS COMPLETE.

Description of Event or Problem · 1

BIOMED REQUESTED A LOG REVIEW OF A CHEMOTHERAPY INFUSION. THE PT WAS TO RECEIVE TWO SEQUENTIAL 24 HOUR INFUSION OF 65MG IV OF DOXORUBICINE. THE FIRST INFUSION COMPLETED ON SCHEDULE AT 1740. THE SECOND INFUSION INFUSED IN 40 MINUTES AND WAS FOUND ALARMING AT 1820 WITH ONLY 2ML LEFT IN THE SYRINGE. THE PT'S MOTHER REPORTED THAT THE PT PUSHED A BUTTON AT THE END OF THE INFUSION. RATE OF INFUSION: 1.35ML/HR. PROFILE: CRITICAL CARE. CONCENTRATION: DOXORUBICIN DISPENSED AS A SYRINGE OF STRAIGHT DRUG (2MG/ML) DOSE: 65MG/32.5ML SYRINGE: 60ML. THERE WAS NO PT HARM REPORTED. CUSTOMER STATED THAT THERE WAS NO INTERVENTION AS A RESULT OF THE INFUSION, HOWEVER, THE PT'S TREATMENT PLAN WILL HAVE TO BE MODIFIED. CUSTOMER ALSO STATED THAT NO FURTHER PT OR EVENT INFO IS AVAILABLE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	ALARIS SYRINGE MODULE		FRN	CAREFUSION CORP.	8110	NA

Patients

Seq	Age	Sex	Outcome	Treatment
1	17 YR			2 ALARIS SYRINGE ADMINISTRATION SETS: MODEL UNK,\| 2 ALARIS PUMP MODULE ADMINISTRATION SETS:MODEL UNK\| 2 ALARIS PUMP MODULE, SNS UNK\| LOT # UNK\| 2 ALARIS SYRINGE MODULES, SNS UNK\| LOT# UNK\| ALARIS PC UNIT: SN UNK