MAUDE Adverse Event Report: HALYARD - IRVINE PM025 SURGPN,270X2D,PM025,-,OQ,5; ELASTOMERIC LFR

Model Number PM025

Device Problem Misconnection (1399)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/05/2017

Event Type  malfunction  

Manufacturer Narrative

The actual complaint product was not returned for evaluation.A review of the device history record is not possible as no lot number was provided.Root cause could not be determined.All information reasonably known as of 02-jul-2017 has been included in this health authority report.Should additional information be obtained, a follow-up health authority report will be provided.The information provided by halyard health represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to halyard health.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).The device was not returned.

Event Description

Fill volume: unknown.Flow rate: unknown.Procedure: open fracture of calcaneus; debridement lower extremity, (wash out), splint application (left).Cathplace: left popliteal.An fda report, fda report number fda 3500 form (b)(4), was received stating: recently in our organization, patient recovering from an orthopedic procedure connected his on-q pump to his peripheral iv.Fortunately, this was immediately identified by the patient's rn.Anesthesia was notified, the patient was monitored, and the on-q pump was discontinued.Manufacturer response for the pain relief system, on-q pump (per reporter): "currently there is not an alternative for the luer's connector's compatibility with standard iv tubing." additional information received 13-jun-2017 stating the catheter insertion site of the peripheral intravenous access (piv) was the left antecubital.The incident occurred in the patient's room.The patient self-taught himself on how to attach the tubing to the catheter, thereby connecting the compatible luer device from the on-q pump to his piv.There was no patient injury identified.Additional information received 14-jun-2017 stating the anesthesiologist initially connected the pain pump however the patient independently disconnected the pump and independently attached it to his piv.The patient was alert and oriented, but was experiencing increased pain.Following identification of the misconnection the patient admitted to connecting the device to the piv to decrease pain.

• Brand Name: PM025 SURGPN,270X2D,PM025,-,OQ,5
• 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, bc 22116 ; MX 22116
• Manufacturer Contact: lisa clark ; 5405 windward parkway; alpharetta, GA 30004 ; 4704485444
• MDR Report Key: 6687212
• MDR Text Key: 79074305
• Report Number: 2026095-2017-00124
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/09/2017

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
• Device Operator: Lay User/Patient
• Device Model Number: PM025
• Device Catalogue Number: 101364000
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/09/2017
• Initial Date FDA Received: 07/05/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: PERIPHERAL IV; ROPIVACAINE
• Patient Age: 49 YR