MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 5.5" EXT SET W/0.2 MICRON FILTER, LUER LOCK; STOPCOCK, I.V. SET

Model Number B1729

Device Problem Material Separation (1562)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 03/04/2021

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Without the returned device a probable cause is unable to be determined.

Event Description

The event involved a 5.5" ext set w/0.2 micron filter, luer lock that the customer reported the tubing pulled out of the hub on the end of the filter set causing blood loss.Maintenance fluids were infusing at the time.The patient had a cbc drawn at 0416 am and the hemoglobin was 10.5 and hematocrit 30.1.The customer reported after the product failure, labs were redrawn at 0922 am and the hemoglobin was 8.3 and the hematocrit was 23.6.The customer reported, as a result of the blood loss and mess, the patient required a clave change and dressing change on the central line, neither of which was scheduled for a several days and the unnecessary dressing change further irritated already fragile skin.Environmental services had to clean the room, crib, toys, and the patient had to be bathed, which is a daily care provided to patients.A blood transfusion was not ordered because the customer stated their lower threshold for transfusions has been set at a hemoglobin of less than or equal to 7 due to blood shortages during the covid pandemic.The customer stated, ¿the set up was iv tubing > spinning spiros > filter set > spinning spiros > clave on end of patient central line.¿ the filter was not cracked.The nurse was able to replicate the failure when testing the filter set on the pod.There was patient involvement and no report of adverse event.

Manufacturer Narrative

No product samples were returned for investigation, however, a photograph was provided and evaluated.The photo shows one list# b1729 extension set, three spiros, and one trifuse extension set.The devices appear to be connected.No damage or anomalies are clearly visible in the image.A device history review (dhr) lot review could not be conducted because no lot number(s) was/were identified.The reported complaint cannot be confirmed based on the information that has been provided.

• Brand Name: 5.5" EXT SET W/0.2 MICRON FILTER, LUER LOCK
• Type of Device: STOPCOCK, I.V. SET
• 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: 11577471
• MDR Text Key: 249730103
• Report Number: 9617594-2021-00101
• 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: 03/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1729
• Device Catalogue Number: B1729
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/31/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPECIFIED INTRAVENOUS SOLUTION, MFR UNK