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 was not returned for evaluation.The reported complaint cannot be confirmed without the returned sample.A device history review (dhr) could not be completed due to the unknown lot number.

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 second occurrence.

• 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
• Manufacturer Contact: emily arnould, bsn, rn ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8894748
• MDR Text Key: 198514762
• Report Number: 9617594-2019-00271
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/01/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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