MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,270X5,HMPMPC,-,LFR-CS,24; ELASTOMERIC PUMP

Model Number C270050

Device Problem Infusion or Flow Problem (2964)

Patient Problems Fatigue (1849); Neuropathy (1983)

Event Date 09/27/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Method: the device was reported to be returning for an evaluation and at this time is pending return.A review of the device history record (dhr) was performed.Results: there are no testing results available as the investigation and evaluation are currently in progress.However, the dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.Conclusions: once the investigation and device analysis are completed 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.

Event Description

Fill volume: asku.Flow rate: asku.Procedure: asku.Cathplace: asku.Please reference: 2026095-2015-00350/15-01128(b), 2026095-2015-00355/15-01128(c), 2015-00356/15-01128(d), 2015-00357/15-01128(e), 2015-00358/15-01128(f), 2015-00359/15-01128(g) and 2015-00360/15-01128(h).It was reported via the medsun importer # (b)(4), received on 11/13/2015 from (b)(6) that a patient reported the following: incident #1 of 8: "last week my chemotherapy pump delivered all of the medication in 2 days rather than 3.I was connected on thursday at 7 p.M.The infusion should have lasted until saturday evening.However, when i checked the device on friday evening it was nearly empty.At my usual 4 a.M.Wake-up time saturday morning, i checked the device and it was completely flat, indicating that the entire dose had completed.This was more than 12 hours ahead of schedule.All day friday and saturday i experienced great fatigue and was unable to do much except keep my eyes open.I also experienced significant neuropathy in both hands making it impossible to open bottles.The neuropathy has subsided but has not completely resolved.I hope you will be able to look into the infusion problem before thursday next week.Last week's experience is not one that i would want to repeat." no further information was provided.

• Brand Name: SURGPN,270X5,HMPMPC,-,LFR-CS,24
• Type of Device: ELASTOMERIC PUMP
• 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-18; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5287701
• MDR Text Key: 33849677
• Report Number: 2026095-2015-00345
• 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: Health Professional
• Type of Report: Initial
• Report Date: 11/13/2015

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?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: C270050
• Device Catalogue Number: 101356802
• Device Lot Number: 0201325987
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Initial Date Manufacturer Received: 11/13/2015
• Initial Date FDA Received: 12/10/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/21/2014
• 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