MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. EXT SET SMALLBORE .2MF PED; INTRAVASCULAR ADMINISTRATION SET

Model Number 10011865

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); Missed Dose (2561)

Event Date 09/28/2020

Event Type  malfunction  

Manufacturer Narrative

Date of birth: unknown.The patient¿s age was used to determine a placeholder date for this field.The initial reporter also notified the fda on 26 october, 2020.Medwatch report # (b)(4).Report source other: medwatch report.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).

Event Description

It was reported that ext set smallbore.2mf ped leaked.The following information was provided by the initial reporter: material #: 10011865; batch/ lot #: 20045504.It was reported that tpn was leaking from the flat circular part of the filter.Verbatim: s: i found that my patient's tpn was leaking from somewhere in the 0.2 micron filter (ref# 10011865).B: on patient assessment, i felt a wet spot on the side rail of the crib around where the tpn tubing was laying.On inspection, it appeared that tpn was leaking from the flat circular part of the filter.I could see liquid appearing out of the filter, but could not see a cracks or breaks in the line or from the actual filter.I notified the medical team and we stopped the tpn infusion and i removed all the tubing and replaced it with maintenance iv fluids.A: since the line was connected to the patient's picc line, i was concerned for infection but luckily this patient is already on an antibiotic.It is also unfortunate that the patient will not be receiving any parenteral nutrition until they can order tpn for the following day.R: i recommend that this product be investigated so that this does not happen again.Since there was no obvious break in the filter, the reason for where and why it was leaking needs to be solved.

Event Description

It was reported that ext set smallbore.2mf ped leaked.The following information was provided by the initial reporter: material #: 10011865 batch/ lot #: 20045504 it was reported that tpn was leaking from the flat circular part of the filter.Verbatim: s: i found that my patient's tpn was leaking from somewhere in the 0.2 micron filter (ref# 10011865).B: on patient assessment, i felt a wet spot on the side rail of the crib around where the tpn tubing was laying.On inspection, it appeared that tpn was leaking from the flat circular part of the filter.I could see liquid appearing out of the filter, but could not see an cracks or breaks in the line or from the actual filter.I notified the medical team and we stopped the tpn infusion and i removed all the tubing and replaced it with maintenance iv fluids.A: since the line was connected to the patient's picc line, i was concerned for infection but luckily this patient is already on an antibiotic.It is also unfortunate that the patient will not be receiving any parenteral nutrition until they can order tpn for the following day.R: i recommend that this product be investigated so that this does not happen again.Since there was no obvious break in the filter, the reason for where and why it was leaking needs to be solved.

Manufacturer Narrative

H6: investigation summary no product or photo was returned by the customer.The customer complaint of leaking from the filter could not be verified due to the product not being returned for failure investigation.The root cause of this failure could not be identified without a failure investigation.A device history record review for model 10011865 lot number 20045504 was performed.The search showed that a total of 8,803 units in 1 lot number was built on (b)(6) 2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.

• Brand Name: EXT SET SMALLBORE .2MF PED
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10865040
• MDR Text Key: 218273477
• Report Number: 9616066-2020-20382
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 50885403233645
• UDI-Public: 50885403233645
• Combination Product (y/n): N
• PMA/PMN Number: K790108
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Type of Report: Initial,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/06/2023
• Device Model Number: 10011865
• Device Catalogue Number: 10011865
• Device Lot Number: 20045504
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 5 MO