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

Model Number	11607704
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/10/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient was a diabetic.Blood glucose lab draw results 325mg/dl, then 249mg/dl.Although requested, product has not been received.A follow up report will be submitted with failure investigation results should the product be received for evaluation.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿patient's gown was wet.Found that the y site of the iv tubing was leaking from the line attached to the insulin drip." it was reported that insulin (100ml) was programed at a rate of 20ml/hr at 0445, and then titrated to a rate of 32ml/hr at 0801.The nurse stated that due to the tubing leak, the patient required more frequent blood glucose labs drawn with results of 325mg/dl and 249mg/dl.Although 'required intervention to prevent impairment/damage' was selected on the medwatch, the customer verified there was no medical intervention provided or patient harm.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿patient's gown was wet.Found that the y site of the iv tubing was leaking from the line attached to the insulin drip." it was reported that insulin (100ml) was programed at a rate of 20ml/hr at 0445, and then titrated to a rate of 32ml/hr at 0801.The nurse stated that due to the tubing leak, the patient required more frequent blood glucose labs drawn with results of 325mg/dl and 249mg/dl.Although 'required intervention to prevent impairment/damage' was selected on the medwatch, the customer verified there was no medical intervention provided or patient harm.
Additional Manufacturer Narrative
The customer¿s report of the "y" site of the iv tubing leaking was confirmed.Microscopic visual inspection observed a permanent puncture hole/tear on the top of the piston.Functional testing confirmed a leak at the location of the puncture hole/tear on the set¿s smartsite valve.No other leaks were observed from any other location on the set.The root cause was determined to be a combination of a minimum of three factors that when all present, increases the likelihood of the fluorosilicone application station on the smartsite automated assembly lines to damage the piston.The three factors are: 1) variations in the piston raw material, 2) variations in the molds and molding process of the piston, and 3) a fluorosilicone pin that is inserted off-center.The type of damage or whether damage occurs is finally influenced by the position of the piston within the assembly.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.Clear liquid was observed in the set¿s drip chamber and the entire length of tubing.The root cause of the piston puncture hole is due to a manufacturing issue of a combination of factors explained in the conclusion.

• Brand Name: ALARIS PUMP MODULE ADMINISTRATION SET
• Common Device Name: SET, ADMINISTRATION, INFUSION
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8875740
• Report Number: 9616066-2019-02189
• Device Sequence Number: 11397192
• Product Code: FPA
• UDI-Device Identifier: 10885403228001
• UDI-Public: 10885403228001
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/08/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19055609
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/08/2019
• Supplement Report FDA Received Date: 10/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 8100,8015,PRI TUBING, TD 07/10/2019; ONE CUROS CAP
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 72 YR
• Patient Weight: 72