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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS SET, ADMINISTRATION, INTRAVASCULAR

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ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number CH2000SC-10
Device Problem Fluid Leak (1250)
Patient Problems No Consequences Or Impact To Patient (2199); Chemical Exposure (2570); Blood Loss (2597)
Event Date 02/01/2020
Event Type  malfunction  
Manufacturer Narrative
A series of photos were returned showing a used ch2000sc-10 spiros connected at the female luer end to the male luer of a cadd extension tubing set. There is no mention or photo provided describing what device was connected at the male luer end of the used ch2000sc-10 spiros. One used (1 unit) list# ch2000sc-10, spiros®, closed male luer w/red cap, 10 units. Lot# 4399288 and one cadd extension tubing lot# 3882412 were returned for evaluation. When spiros was pressure leak tested while still connected to the cadd extension tubing set (activated position during testing) and was subsequently removed and tested stand alone in the unactivated position. There was no leakage observed in either position. The complaint of leakage can be confirmed with the returned photographs, however, the leakage could not be replicated during testing. The probable cause of the leakage during use cannot be determined. A device history review (dhr) for lot# 4399288 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint. 5fu, mfr unk; unspec cadd extension tubing, lot number 3882412, mfr smith medical; cadd ambulatory infusion pump, model 6500, mfr smith medical.
 
Event Description
The event occurred on an unspecified date and involved a spiros closed male luer w/red cap that leaked from the spiros where it was connected to the male port. The customer reported fluid and blood seeped so much it was reported to look like a gunshot wound. The spiros was connected to a cadd extension tubing and was infusing 5fu via a cadd ambulatory infusion pump; after 24 hours into a 48 hours infusion, a leak was noted, reporting the medication leaked onto the patient twice. It was reported that the device leaked twice during the night, once from the top of the spiros and once from the bottom of the spiros. The tubing was not replaced, the patient still had 3. 2ml to infuse out of 100ml programmed. There were no holes, cuts, tears or defected noted on the device. There was no delay in critical therapy reported.
 
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Brand NameSPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.
avenida cuarzo no. 250
ensenada, b.cfa. 22790
MX 22790
Manufacturer Contact
christopher zanoni
600 n. field dr.
lake forest, IL 60045
2247062300
MDR Report Key9782385
MDR Text Key224634211
Report Number9617594-2020-00060
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K070532
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/14/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberCH2000SC-10
Device Lot Number4399288
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/18/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/14/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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