SPIROS

Report

Report Number: 2025816-2010-00130
Event Type: Malfunction
Date Received: March 21, 2011
Date of Event: November 10, 2010
Report Date: November 12, 2010
Manufacturer: ICU MEDICAL, INC.
Product Code: FPA
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: LA, US
Reporter Occupation: PHARMACIST

Narratives

Additional Manufacturer Narrative · 1

MFR'S DEVICE ANALYSIS: ONE (1) USED 20130-01 SPIROS CONNECTOR ATTACHED TO ALARIS PUMP SET (MODEL/CATALOG # UNK). FUNCTIONAL TESTING WAS PERFORMED. THE SPIROS AND ALARIS SET EXHIBITED NO ATTACHMENT ISSUES. THE SPIROS AND ALARIS SET WERE LEAK TESTED, IN THE ACTIVATED AND INACTIVATED POSITIONS AT 20 PSIG. THE RESULTS RECORDED NO LEAKAGES OR FLOW ISSUES. ADD'L TESTING WAS THEN CONDUCTED REPLICATING SET-UP AT 36" HEAD HEIGHT FOR 3 HOURS. THE RESULTS RECORDED NO LEAKAGE OR FLOW ISSUES. ADD'L ENGINEERING EVAL OF THE RETURNED SPIROS CONNECTOR COMPONENT(S) IDENTIFIED NO ABNORMALITIES AND/OR OUT OF SPEC CONDITIONS. CONCLUSION: UNABLE TO REPLICATE THE REPORTED LEAKAGE PROBLEM AND OR CONFIRM A MFG DEFECT. THE EXACT CAUSE OF THE EVENT CANNOT BE DETERMINED AT THIS TIME.

Description of Event or Problem · 1

COMPLAINT REC'D REPORTING ATTACHMENT/LEAKAGE ISSUES WITH USE OF ONE (1) 20130-01 SPIROS CONNECTOR AND ALARIS TUBING SET. IT WAS REPORTED THAT ON (B)(6) 2010 THERE WAS A "... TAXOTERE CHEMO LEAK (EST.) 100 CC FROM THE SPIROS AND TUBING ATTACHMENT." THE CHEMO DID LEAK ON THE PT, WHO WAS TREATED VIA HOSP PROTOCOL (TOPICAL CLEANSING SOLUTION) AND EXPERIENCED NO ADVERSE SYMPTOMS. ADD'L STATEMENTS MADE THAT "IT COULD NOT BE DETERMINED HOW MUCH CHEMO PT HAD ACTUALLY REC'D, DOSAGE WAS COMPROMISED." THE NURSES ATTENDING TO THE CLEAN-UP OF THE SPILL EXPERIENCED HEADACHES, THROAT AND CHEST IRRITATIONS WHICH DID SUBSIDE.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
1	SPIROS	CLOSED MALE CONNECTOR	FPA	ICU MEDICAL, INC.	20130-01	UNK

Patients

Seq	Age	Sex	Outcome	Treatment
1				ALARIS TUBING SET