MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X5,HMPMPC,-,LFR-CS,24; HOMEPUMP C-SERIES: 270ML, 5ML/HR

Model Number C270050

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Tingling (2171); Abdominal Cramps (2543); Lethargy (2560)

Event Date 08/11/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: at the time of this report the device has not yet been received.A review of the device history record (dhr) has been conducted.Results: according with the results of the dhr review, the production lot met all manufacturing and quality specifications.Testing results of the device are pending.Conclusion: a complete investigation is currently in progress.The information reported was that the device was accidently used on this patient.The order was written for 2ml/hr to infuse in 4 days (98 hours).The 192ml's was accidently put into a 270ml x 5ml/hr pump.Once the device is received, testing and analysis will be conducted.Upon completion of our investigation a follow-up report will be submitted.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Pending receipt of device.

Event Description

Fill volume: 192ml; flow rate: 5ml/hr; procedure: chemotherapy; cath.Placement: port-o-cath.A safety officer from hospital called to report that a wrong pump was accidentally used and the infusion of 5fu finished early.It was reported as "patient was getting 5fu and it was ordered to go in over 4 days at 2ml/hr.It was accidentally put in a 5ml/hr 270 and only filled to the 192ml that was ordered so the faster pump was under filled.Started monday at 1600 and by pm tuesday it was empty." the patient experienced abdominal cramping gi symptoms, light headedness, tingling in fingers, and lethargic.The infusion went in 28hrs vs 98 hours as prescribed.By (b)(6) the patient was in the er feeling really sick, and was hospitalized.Additional information was received on (b)(6) 2015.The patient is still hospitalized right now to receive antidote treatment and is currently recovering.

Manufacturer Narrative

(b)(4).Method: a review of the device history record (dhr) has been conducted.Results: according with the results of the dhr review, the production lot met all manufacturing and quality specifications.Conclusion: the information reported was that the incorrect device was accidently used on the patient.The order was written for 2ml/hr to infuse in 4 days (98 hours).The 192ml's was accidently put into a 270ml x 5ml/hr pump.It was reported on (b)(6) 2015 by the reporter that there is now a pending litigation case between the patient's family and the hospital, as the hospital used the wrong pump in error.Therefore, the hospital cannot release the pump for return.As the device analysis cannot be performed, we are unable to determine the cause of the reported event.Information from this incident has been included in our product complaint reporting systems for monitoring, tracking and trending purposes.Device not returning for evaluation.

• Brand Name: SURGPN,270X5,HMPMPC,-,LFR-CS,24
• Type of Device: HOMEPUMP C-SERIES: 270ML, 5ML/HR
• 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.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5058402
• MDR Text Key: 25106970
• Report Number: 2026095-2015-00226
• 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: health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Followup
• Report Date: 08/12/2015

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: C270050
• Device Catalogue Number: 101356802
• Device Lot Number: 0202012483
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 09/04/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/16/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/28/2014
• 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
• Patient Outcome(s): Hospitalization; Other
• Patient Age: 51 YR