MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER; STOPCOCK, I.V. SET

Model Number B1339

Device Problems Disconnection (1171); Fluid/Blood Leak (1250)

Patient Problems Hemorrhage/Bleeding (1888); Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/16/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available to be returned for evaluation; however, it has not yet been received.

Event Description

The event involved an 8" ext set with 0.2 micron filter, clamp, rotating luer where the 0.2 micron filter detached at the hub, making an open system.During an infusion of carboplatin, the patient called the nurse where it was found that blood and fluid was on the blanket, chair, and the patient¿s clothing.Blood was reported to be flowing from a line that was not being used, that had previously been infusing paclitaxel.The filter from the paclitaxel line was found to be disconnected from filter and the filter tubing was disconnected from hub.The line was clamped with kelly clamp.The carboplatin and main line were paused.Approximately 100ml was remaining in carboplatin bag.The spill was cleaned up per protocol using a spill kit.The tubing was not replaced, the therapy was not resumed.A verbal order was given by the nurse practitioner to not give the remaining carboplatin.There was no hole, cut, tears or defect noted.There was patient involvement, and although there was unprotected chemo exposure to the patient and/or the healthcare provider reported, there was no patient harm reported.

Manufacturer Narrative

A photograph of the used device in a plastic bag was provided.No damage or anomalies are clearly visible in the image.One used partial list #b1339, 8" ext set with 0.2 micron filter, clamp, rotating luer (lot #4799629), one used unknown infusion set, one used baxter nacl 0.9% 250 ml intravenous bag, one used extension set with chemolock port and spiros (list# unknown, lot #unknown) and one used fresenius kabi freeflex 500 ml sodium chloride 0.9% injection were received and visually inspected.As received, the tubing was missing from the outlet post of the 0.2 micron filter on the b1339 extension set.The missing tubing was not returned.Some solvent was observed on the outlet post of the filter.No damage or anomalies were observed on the returned mating devices.The comparable bond on the set was pull tested and met product performance specifications.The solvent coverage on the pulled inlet post was compared to the solvent coverage on the outlet post.The coverage was similar in appearance.The reported complaint of a tubing separation can be confirmed; however, without the return of the separated tubing a probable cause cannot be determined.Additional information: h6 health effect - clinical code.D9 - date returned to mfg: 19-apr-2021.

• Brand Name: 8" EXT SET WITH 0.2 MICRON FILTER, CLAMP, ROTATING LUER
• 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: 11599960
• MDR Text Key: 243344530
• Report Number: 9617594-2021-00108
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00887709001190
• UDI-Public: (01)00887709001190(17)250401(10)4799629
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 03/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1339
• Device Catalogue Number: B1339
• Device Lot Number: 4799629
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: CARBOPLATIN, MFR UNK; PACLITAXEL, UNK MFR; UNSPEC TUBING SET, MFR UNK