MAUDE Adverse Event Report: CAREFUSION SD ALARIS PUMP MODULE ADMINISTRATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 2420-0007

Device Problems Excess Flow or Over-Infusion (1311); Appropriate Term/Code Not Available (3191)

Patient Problems Venipuncture (2129); No Consequences Or Impact To Patient (2199)

Event Date 11/27/2019

Event Type  malfunction  

Manufacturer Narrative

The customer¿s report of a free flow of lasix was not confirmed.Investigation conclusion: the report of a free flow of lasix was neither confirmed nor replicated.The pcu event log contained no obvious programming errors that would result in the reported event.The volume recorded as being infused between 11:19 am on (b)(6) 2019 to 7:37 am on (b)(6) 2019 was 99.37ml.A review of the device error logs found no errors during the time period of the reported event.Functional testing performed found the pump module to be delivering fluid within specification.The mechanism assembly was completely disassembled, and no anomalies were noted that could have contributed to the reported issue.Leaking was observed from a pinhole tear in the silicone tubing near the upper fitment from the returned primary set (model 2420-0007).Crush marks were not observed on either the upper or lower fitment and leaking was not reported by the customer, so it is unknown if the pinhole tear occurred during transport of the set for investigation.The source disposable set (model 2420-0007) was evaluated for concentricity and was found to be within specification.The root cause of the report of a free flow of lasix was not identified.

Event Description

It was reported that a lasix (5mg/hr.) infusion was initiated at 1119 on (b)(6) ; at 0227, the volume to be infused (vtbi) was decreased from 100 to 80.By 0616, the device alarmed for ail and the lasix bag was empty.The programmed rate and amount was verified to be infusing at the ordered dose of 5mg/hr, and it was confirmed that from (b)(6) 2019 at 1700 to (b)(6) 2019 at 0616, 65.78mls were infused.In addition it was verified that only 23.8mls were infused from 0227 until 0737, despite the bag being empty.It was later reported that the patient was already in the icu, close monitoring was continued, and the physician ordered a basic metabolic profile (bmp) lab test after the lasix infusion, however there was no patient impact reported.The facility biomed retested the device, however was unable to duplicate the problem of free-flow.Received a copy of the customer's sus voluntary event report from fda which states: ¿pt received 100 mg of iv lasix in 5 hour period when iv pump was set to infuse 5 mg/hr of iv lasix rn hung new bag of lasix containing 100 ml and used the a laris pump and bd alaris pump infusion set (tubing) the lasix was run as a continuous drip at 5 mg/hr the rn started the lasix medication on (b)(6) 2019 at 0227 the rn reports they changed ute volume to be infused from 100ml to 80 ml and verified the pump was running at the correct rate on (b) (6) 2019 at 0616, rn reports iv pump was alarming with an air in line message and the lasix bag was empty the pump also showed only 23 8mls were infused during this time when in fact around 100ml had infused into the patient additionally, we have had 3 other events since (b)(6) 2018 in which the iv infusion bypassed the programmed rate and infused the entire bag all infusions were with the bd alaris 8100 model pump and the bd alaris pump infusion set the first pump (b)(6) 2018, was sent to bd alaris for review and returned to us without the company finding an issue the remaining pumps (event date (b)(6) 2019 - serial number (b)(4), (b)(6) 2019 - serial number (b)(4), (b)(6) 2019, serial number (b)(4)) have all been sent to the bd alaris company for review".

Manufacturer Narrative

The customer¿s report of a free flow of lasix was not confirmed.Investigation conclusion: the report of a free flow of lasix was neither confirmed nor replicated.The pcu event log contained no obvious programming errors that would result in the reported event.The volume recorded as being infused between (b)(6) 2019 to (b)(6) 2019 was 99.37ml.A review of the device error logs found no errors during the time period of the reported event.Functional testing performed found the pump module to be delivering fluid within specification.The mechanism assembly was completely disassembled, and no anomalies were noted that could have contributed to the reported issue.Leaking was observed from a pinhole tear in the silicone tubing near the upper fitment from the returned primary set (model 2420-0007).Crush marks were not observed on either the upper or lower fitment and leaking was not reported by the customer, so it is unknown if the pinhole tear occurred during transport of the set for investigation.The source disposable set (model 2420-0007) was evaluated for concentricity and was found to be within specification.The root cause of the report of a free flow of lasix was not identified.

Event Description

It was reported that a lasix (5mg/hr.) infusion was initiated at on (b)(6)2019, the volume to be infused (vtbi) was decreased from 100 to 80.By 0616, the device alarmed for ail and the lasix bag was empty.The programmed rate and amount was verified to be infusing at the ordered dose of 5mg/hr, and it was confirmed that from (b)(6)2019 at 1700 to (b)(6)2019 at 0616, 65.78mls were infused.In addition it was verified that only 23.8mls were infused from 0227 until 0737, despite the bag being empty.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer (Section G): CAREFUSION SD; 10020 pacific mesa blvd; san diego CA 92121 4386
• Manufacturer Contact: ade ajibade ; 10020 pacific mesa blvd; san diego, CA 92121-4386 ; 8586172000
• MDR Report Key: 9750912
• MDR Text Key: 204397640
• Report Number: 9616066-2020-00382
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 07613203021012
• UDI-Public: 7613203021012
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K944320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/14/2022
• Device Model Number: 2420-0007
• Device Catalogue Number: 2420-0007
• Device Lot Number: 19106054
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/27/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/14/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 8015,(2)PRI TUBING,(2)8100, TD: (B)(6) 2019.
• Patient Age: 46 YR
• Patient Sex: Male
• Patient Weight: 79 KG