MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO; ADMINISTRATION SETS AND ACCESSORIES

Model Number B33098

Device Problem Material Separation (1562)

Patient Problem Blood Loss (2597)

Event Date 02/17/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to be returned for investigation.It has not yet been received.

Event Description

The customer contact reported the tubing set detached from the trifuse connection and the spiros cap, which then disconnected from the central line.At which time, blood was found all over the bed and patient.There was patient involvement with an unspecified minor adverse event and intervention.No further information has been provided.

Manufacturer Narrative

Additional information was obtained from the customer.The disconnection was noted during the change of shift safety check, while iv fluid was infusing.The patient was stable before, during and after the event, although the hemoglobin dropped.The medical intervention provided was the following: the tubing set was replaced, blood was drawn to assess blood count, and a blood transfusion was completed.The customer was unable to confirm if the blood transfusion was due to the patient¿s condition or the actual event.Testing and investigation received the tubing set for evaluation.No visual anomalies were observed.The spin collar retention of the used b33098 trifuse extension set was measured and found to meet product performance expectations outlined in the iso design guidance.If the spin feature of a spinning spiros is not activated during use, any rotation in the disconnect direction could result in a disconnect from a mating device during use.The lot number was not provided; thus, a manufacturing batch record review could not be completed.

• Brand Name: 4" (10 CM) APPX 0.40 ML, SMALLBORE TRIFUSE EXT SET W/3 MICROCLAVE®, 3 CLAMPS, RO
• Type of Device: ADMINISTRATION SETS AND ACCESSORIES
• 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: 8425597
• MDR Text Key: 139322317
• Report Number: 9617594-2019-00078
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• 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: 02/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: B33098
• Device Catalogue Number: B33098
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 02/27/2019
• Initial Date FDA Received: 03/15/2019
• Supplement Dates Manufacturer Received: 03/28/2019
• Supplement Dates FDA Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED CENTRAL LINE.
• Patient Outcome(s): Required Intervention