MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD¿ MICROBORE EXTENSION SET WITH ANTI-SIPHON VALVE PINCH CLAMP; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 30862

Device Problem False Alarm (1013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/27/2022

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a 30862 sample was not available for investigation; however, the customer confirmed the complaint sample was from lot: 21015405.The feedback provided by the customer indicates an occlusion alarm was detected at the start of a remifentanil infusion.The customer also confirmed the 30862 extension set was connected to an unknown 50ml syringe.As part of the investigation, the customer provided a video of their experience.Analysis of the video confirms their experience as at the start of infusion the arcomed pump alarmed occlusion; however no obvious manufacturing defects were observed to the 30862 extension set which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot: 21015405 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the complaint sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 30862 product in the past 12 months.

Event Description

It was reported that the bd¿ microbore extension set with anti-siphon valve pinch clamp caused the air-in-line alarm to trigger when used with the pca remifentanil.The following information was provided by the initial reporter: "we have physical samples from 2 batches and have removed the faulty batch none of the sample have been used clinically.These are clean samples tested to confirm the problem.No chemotherapy.We have a batch (lot: (10)21015405) of these that cause high pressure alarm to be triggered when used with pca remifentanil.".

Event Description

It was reported that the bd¿ microbore extension set with anti-siphon valve pinch clamp caused the air-in-line alarm to trigger when used with the pca remifentanil.The following information was provided by the initial reporter: "we have physical samples from 2 batches and have removed the faulty batch none of the sample have been used clinically.These are clean samples tested to confirm the problem.No chemotherapy.We have a batch (lot (10)21015405) of these that cause high pressure alarm to be triggered when used with pca remifentanil.".

Manufacturer Narrative

H.6.Investigation summary: a 30862 sample was not available for investigation; however, the customer confirmed the complaint sample was from lot 21015405.The feedback provided by the customer indicates an occlusion alarm was detected at the start of a remifentanil infusion.The customer also confirmed the 30862 extension set was connected to an unknown 50ml syringe.As part of the investigation, the customer provided a video of their experience.Analysis of the video confirms their experience as at the start of infusion the arcomed pump alarmed occlusion; however no obvious manufacturing defects were observed to the 30862 extension set which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21015405 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the complaint sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.A review of the customer feedback database indicates that this is an isolated feedback with no further reports of this nature against the 30862 product in the past 12 months.H3 other text : see h.10.

Event Description

It was reported that the bd¿ microbore extension set with anti-siphon valve pinch clamp caused the air-in-line alarm to trigger when used with the pca remifentanil.The following information was provided by the initial reporter: "we have physical samples from 2 batches and have removed the faulty batch none of the sample have been used clinically.These are clean samples tested to confirm the problem.No chemotherapy.We have a batch (lot (10)21015405) of these that cause high pressure alarm to be triggered when used with pca remifentanil.".

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, returned to manufacturer on: 19-oct-2022.Investigation summary: three 30862 samples from lot 21015405 were received in opened packaging for investigation one of the samples was received cut in half.Residual fluid was detected in the sample; however no residual fluid was detected in the remaining two samples.Two 50ml bd plastipak syringes were also received to assist the investigation.The feedback provided by the customer indicates occlusion alarms were detected by the arcomed pump at the start of a remifentanil infusion.As part of the investigation, the customer provided a video of their experience; analysis of the video confirmed the customer's experience as at the start of infusion the arcomed pump alarmed occlusion.A visual inspection of the returned samples did not identify any signs of damage or manufacturing defects which could have contributed to the reported occlusion alarms.Functional testing was performed by connecting the two 50ml bd plastipak syringes returned by the customer in addition to a 50ml bd plastipak syringe from stock and attempting to flush the samples with fluid; no occlusions or flow restrictions were detected from all three samples.Further functional testing involved connecting the samples to a bd alaris pk pump from stock and subjecting to a short infusion at 75ml/h, with an occlusion threshold of l3; in each instance no pump alarms were detected with the infusion completing successfully.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21015405 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In this instance, a definitive root cause could not be identified as testing of the returned samples did not identify any product defects that could have contributed to the customers experience.

Manufacturer Narrative

H6: investigation summary: a 30862 sample was not available for investigation; however, the customer confirmed the complaint sample was from lot 21015405.The feedback provided by the customer indicates an occlusion alarm was detected at the start of a remifentanil infusion.The customer also confirmed the 30862 extension set was connected to an unknown 50ml syringe.As part of the investigation, the customer provided a video of their experience.Analysis of the video confirms their experience as at the start of infusion the arcomed pump alarmed occlusion; however no obvious manufacturing defects were observed to the 30862 extension set which may have contributed to the customer's experience.The details of this feedback were forwarded to the manufacturing site for investigation.A review of the production records for lot 21015405 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.The root cause of the customer¿s experience could not be determined as the complaint sample was not available for investigation.In this instance, without a sample, it is not possible to determine whether a manufacturing defect could have caused or contributed to the customer¿s experience.H3 other text : see h.10.

Event Description

It was reported that the bd¿ microbore extension set with anti-siphon valve pinch clamp caused the air-in-line alarm to trigger when used with the pca remifentanil.The following information was provided by the initial reporter: "we have physical samples from 2 batches and have removed the faulty batch none of the sample have been used clinically.These are clean samples tested to confirm the problem.No chemotherapy.We have a batch (lot (10)21015405) of these that cause high pressure alarm to be triggered when used with pca remifentanil.".

• Brand Name: BD¿ MICROBORE EXTENSION SET WITH ANTI-SIPHON VALVE PINCH CLAMP
• 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
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15261811
• MDR Text Key: 305421564
• Report Number: 9616066-2022-01198
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 11/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/19/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/06/2024
• Device Catalogue Number: 30862
• Device Lot Number: 21015405
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/28/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1