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

Model Number	11607704
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/27/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Report source: biomed information & analytics services.The customer¿s reported complaint of medication not flowing, not coming out of the end of the line when programmed to infuse was not definitely confirmed.However, during the investigation abnormal slow fluid flow was observed at the end of the line, filling the primary set drip chamber with fluid.Log analysis results suspects the time of the incident most likely occurred between 5:23 am and 6:32 am on (b)(6) 2019.Testing demonstrated the source pump module passing a rate accuracy test utilizing the timed rate accuracy test method.Results confirmed the device is in specification and operating as intended.However, a functional test and a check valve test identified a failure with the check valve component, allowing fluid to back flow up into the primary set from the secondary bag.It is suspected that during the incident, the check valve failure caused an abnormal slow flow of medication at the end of the line appearing to the user as no flow.The proximate root cause of the customer¿s experience with no flow of medication during a programmed infusion was most likely attributed to a check valve failure on the primary set during a secondary infusion.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿secondary medication was hung by when the rn started the pump medication was not coming out of the end of the line - drips in drip chamber." it was reported that keppra (1000mg/100ml) was programmed at a rate of 400ml/hr.However when the device was programmed to infuse the medication would not flow.The customer stated that there was no patient harm.
Additional Manufacturer Narrative
Supplemental report to reflect the correct aware date (b)(6) 2019 for e-mdr pr: 328117, as the wrong reportable aware date was placed in (g.4); this was not a late report.
Event or Problem Description
Received a copy of the customer's medwatch report from fda which states, ¿secondary medication was hung but when the rn started the pump medication was not coming out of the end of the line - drips in drip chamber" it was reported that keppra (1000mg/100ml) was programmed at a rate of 400ml/hr.However when the device was programmed to infuse the medication would not flow.The customer stated that there was no patient harm.

• 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: 9205209
• Report Number: 9616066-2019-02929
• Device Sequence Number: 19495131
• 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?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: 11607704
• Device Catalogue Number: 11607704
• Device Lot Number: 19055962
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/08/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 11/08/2019
• 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: (4) 8100, 8015, 11448964, THERAPY DATE (B)(6) 2019
• Patient Age: 50 YR
• Patient Weight: 99