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
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	10/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received for evaluation.Investigation is pending.
Event or Problem Description
The event occurred on unspecified dates and involved at least a dozen spiros®, closed male luer w/red cap, 10 units that had leaks of various, multiple chemo infusions occurring at the spiros at the distal end of the ambulatory pump tubing, and the connection to the patient.The leaking occurred at the infusion suite and the patient experienced the fluid getting on them.The customer reported that the chemo bags come out primed from the pharmacy, so most likely, the event occurred during hook-up, or infusion.The customer reported the possible mating devices were a clave connector, or safe day extension set.The chemo spill was cleaned up per facility protocol, and new bags were made, therapy resumed, and no spiros were attached to replacements.There were no holes, cuts, tears, or any defects noted on the device.There was patient involvement, and no adverse event.
Additional Manufacturer Narrative
H10 - one used unit from list #ch2000sc-10, spiros®, closed male luer w/red cap, (b)(4) units; (lot #4976352), five new list #ch2000sc-10, spiros®, closed male luer w/red cap, (b)(4) units; (lot #4976352), one unknown elastomeric pump set, and one 10 ml bd syringe were received and visually inspected.As received, the spin feature of the used spiros was activated and spinning freely.No spline damage or shear tab anomalies were seen.The used spiros was returned securely connected to the male luer of the elastomeric pump.Red fluid residuals were present within the luer threads of the male luer.How the residuals were created is unknown.The dfu states: to prevent the possibility of leakage when the spiros is connected to the end of an elastomeric infusion pump, activate the clamp on the pump line and/or connect the spiros to the female port of the elastomeric pump in order to make a closed fluid circuit.No damage or anomalies were found on the fifty new spiros units.The luers of all returned samples were measured and found to meet iso standards for luer fittings.The activation, residual, and disconnect torque value of each new sample was measured.All samples met product performance specifications.The samples showed no evidence of a spin feature malfunction that would result in a disconnection.The reported complaint of a disconnection cannot be confirmed.The lot history was reviewed and there were no nonconformities reported that could have attributed to the complaint.

• Brand Name: SPIROS, CLOSED MALE LUER W/RED CAP, 10 UNITS
• Common Device Name: 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
• MDR Report Key: 10833117
• Report Number: 9617594-2020-00486
• Device Sequence Number: 19567613
• Product Code: FPA
• UDI-Device Identifier: 00840619042769
• UDI-Public: (01)00840619042769(17)250801(10)4976352
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K070532
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 10/15/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 08/01/2025
• Device Catalogue Number: CH2000SC-10
• Device Lot Number: 4976352
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/04/2020
• Initial Date Received by Manufacturer: 10/22/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/12/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: UNSPEC AMBULATORY PUMP TUBING, MFR UNK.