MAUDE Adverse Event Report: HALYARD - IRVINE HOMEPUMP C-SERIES: 270ML, 1ML/HR; ELASTOMERIC LFR

Model Number C270010-10

Device Problem Infusion or Flow Problem (2964)

Patient Problem Diarrhea (1811)

Event Date 07/20/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.As the lot number is unknown, a review of the device history record (dhr) was not performed.Results: as the device was unavailable for analysis, no methods were performed.Therefore, results cannot be obtained.Conclusions: the device was not returned to halyard for evaluation therefore, we are unable to determine the cause for the reported event.Halyard health has no independent knowledge of the event reported but is relaying the information that was provided by the user facility where the incident occurred.(b)(4).

Event Description

Fill volume: 199 ml, flow rate: 1 ml/hr, cathplace: intravenous, pump start time: 1210, pump end time: not provided.It was reported that an infusion pump ended 40 hours too early.The incident occurred in the patient's home, and resulted in significant diarrhea eight times a day for five to six days.The patient's chemotherapy was delayed for one week as a result in order to allow multiple days for hydration.

• Brand Name: HOMEPUMP C-SERIES: 270ML, 1ML/HR
• Type of Device: ELASTOMERIC LFR
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V.; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6059423
• MDR Text Key: 58456894
• Report Number: 2026095-2016-00183
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK052117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/06/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: C270010-10
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Other Device ID Number: 10680651348811
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: 5FU; UNKNOWN CATHETER
• Patient Age: 76 YR
• Patient Weight: 102