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

Catalog Number CH2000SC-10

Device Problem Fluid/Blood 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.

• Brand Name: SPIROS®, CLOSED MALE LUER W/RED CAP, 10 UNITS
• Type of Device: SET, 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 Key: 9782385
• MDR Text Key: 224634211
• Report Number: 9617594-2020-00060
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)241001(10)4399288
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K070532
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 4399288
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/14/2020
• Initial Date FDA Received: 03/03/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1