MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,400X2-14,PMPSAF,-,OQ,5; ELASTOMERIC - SAF

Model Number P400X2-14

Device Problem Infusion or Flow Problem (2964)

Patient Problem Respiratory Distress (2045)

Event Date 03/30/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the actual device was not returned.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.This product incident is documented in the halyard health complaint database and identified as complaint (b)(4).Device not returned.

Event Description

Fill volume: 500 ml; flow rate: unknown ; procedure: labrum repair to left shoulder; cathplace: supraclavicular block.A report was received stating that 2-days after the procedure the patient had a reaction of shortness of breath.The patient called the nurse hotline and the patient was instructed to clamp the pump.The hotline nurse instructed the patient to call the anesthesiologist and have a family member take the patient to the emergency room.It was noted by the patient that the pump was working fine and contained the medication.A follow-up call was placed to the physician.The physician reported the patient was admitted to the hospital for shortness of breath.The physician reported the surgeon had the catheter pulled.The physician reported the patient had multiple comorbidities.The physician reported the patient, " was baseline sick, this probably turned into something a bit bigger than it needed to be." additional information received on 01-apr-2016 stated the patient is currently doing well.He currently denies any shortness of breath and is in stable condition.It was noted that in the emergency room the patient's pump was removed and the patient was administered breathing treatments.The patient was given albuterol.The patient was then placed in an observation unit and discharged that same day, (b)(6) 2016 at 546pm.The patient was discharged with a prn (as needed) breathing inhaler.The patient had anesthetics in the past and had not had any complications or issues during use.The patient did not take any pain medications simultaneously during the incident.The patient pain was well managed by the pump.The patient did not exhibit any other signs of toxicity.The patient was not discharged with a serious injury or permanent damage to his body.No further information to be provided.

• Brand Name: SURGPN,400X2-14,PMPSAF,-,OQ,5
• Type of Device: ELASTOMERIC - SAF
• 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: 5609437
• MDR Text Key: 43714384
• Report Number: 2026095-2016-00037
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/30/2016

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: Physician
• Device Model Number: P400X2-14
• Device Catalogue Number: 101368500
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/30/2016
• Initial Date FDA Received: 04/26/2016
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 67 YR
• Patient Weight: 104