MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-C

Device Problem Disconnection (1171)

Patient Problems No Consequences Or Impact To Patient (2199); Blood Loss (2597)

Event Date 05/02/2020

Event Type  malfunction  

Manufacturer Narrative

It is unknown if the device is available for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.A device history review (dhr) could not be completed due to the unknown lot number.If additional information is received, supplemental reports will be submitted.

Event Description

The customer reported a spinning spiros closed male luer, red cap that became undone and blood had spilled out of the patient's line and onto the bed.The nurse paused the chemo, followed the line, and noticed the spiros had been undone.There was patient involvement but no harm reported.This report captures the first of three events.

Event Description

User facility mandatory medwatch (0504540000-2020-b012) was received which stated "during chemo administration, patient's father called and notified rn to come into room asap.Rn found that the chemo line became undone and blood had spilled out of pt's line and onto the bed.Rn paused the chemo, followed the line and noticed that the spiros connector had come undone accidentally.Rn alerted resource rn to take another look.Rn and resource rn brought in new tubing line.Per dad, patient did not manipulate the line as they were just sitting in the bed playing with toys.Md and pharmacy were notified.".

Manufacturer Narrative

H10: no product samples, videos, or photographs were returned for investigation.A probable cause cannot be identified based on the information that has been provided.Additional information in a2, a3, b5, d10, e4, f2.Additional initial reporter address information: (b)(6) medical center.(b)(6).

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• Type of Device: 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: 10124803
• MDR Text Key: 219530186
• Report Number: 9617594-2020-00161
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 05/15/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 1 YR