MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPIROS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number UNKNOWN

Device Problem Fluid/Blood Leak (1250)

Patient Problem Blood Loss (2597)

Event Date 07/13/2019

Event Type  malfunction  

Manufacturer Narrative

The list number and lot number of the device that was in use is unknown.The customer identified the device as a single spiros; however, the customer did not provide the list or lot number of the device.The device has been returned for evaluation.Testing is not complete.

Event Description

The event involved an unspecified spiros connector that partially disconnected twice from the end of a large bore hazardous drug line.Blood was noted to be backing up into the tubing and out of the line.The connections were checked, the c-clamp was present and the tubing end was twisted until completely engaged.However; the tubing was still able to disconnect from spiros.The tubing was replaced with no further problems.The report reflects the first occurrence.

Manufacturer Narrative

H10 - one used spiros list number unknown, lot number unknown and a partial mating device of unknown list number and lot number were received for evaluation.The spinning spiros was confirmed to have damage consistent with a disconnect during use.The spin feature was activated but it appeared that the shear tab had an incomplete separation which resulted in interference with the splines of the collar and a dome shaped groove being worn into the splines.The probable cause of this type of disconnect is due to an incomplete shear tab separation that can result in binding the spin feature.No device history review was conducted because no lot number was identified.Additional information can be found in section g1.

• Brand Name: SPIROS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8894743
• MDR Text Key: 203307051
• Report Number: 9617594-2019-00270
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 08/01/2019
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC IV TUBING SET.