MAUDE Adverse Event Report: PALL LIFE SCIENCES PUERTO RICO, LLC PALL POSIDYNE® ELD FILTER; EXTENDED LIFE DISPOSABLE FOR IV THERAPY

Model Number ELD96LYLS

Device Problems Crack (1135); Reflux within Device (1522)

Patient Problems Dyspnea (1816); Low Blood Pressure/ Hypotension (1914); Tachycardia (2095); Low Oxygen Saturation (2477); Underdose (2542)

Event Date 04/05/2015

Event Type  Injury  

Event Description

It was reported that during the administration of medication (flolan) a filter crack was observed in a pall posidyne® eld filter, p/n eld96lyls, lot# 502311.No observation of a leak from the crack was reported.It was reported that the medication (flolan) appeared to be backing up and did not appear to be infusing.It was reported that the patient decompensated whereby the patient's oxygen level decreased, became hypotensive, tachycardic and short of breath.The patient required the administration of bipap, increased oxygen, sedation and inotropes for approximately 5 hours.Additional patient information has been requested from the customer and is pending.(b)(6) medical director will review on receipt.

Manufacturer Narrative

It has been communicated by the customer that the implicated sample is not available to be returned for investigation.A review of the manufacturing of implicated lot 502311 is being conducted but not yet complete.A final mdr will be submitted upon completion.A review of our customer complaint records, over the past two years, has confirmed that no other reports of a cracked filter for part eld96lyls were received.

Manufacturer Narrative

The involved device was not retained by the customer, so a direct evaluation was not possible.Numerous attempts were made to obtain additional information from the customer and to confirm the patient's status after medical intervention was provided.The customer did not respond to our attempts.For the reasons above no further evaluation could be conducted.As was mentioned in the firm's initial medwatch report, a review of our manufacturing records was conducted and has confirmed that product code eld96lyls lot # 502311, and the filter lot numbers incorporated into eld96lyls lot # 502311 were all manufactured and quality control tested in accordance.

• Brand Name: PALL POSIDYNE® ELD FILTER
• Type of Device: EXTENDED LIFE DISPOSABLE FOR IV THERAPY
• Manufacturer (Section D): PALL LIFE SCIENCES PUERTO RICO, LLC; carr. 194, pall blvd no 98; fajardo PR 00738
• Manufacturer (Section G): PALL LIFE SCIENCES PUERTO RICO, LLC; carr. 194, pall blvd no 98; fajardo PR 00738
• Manufacturer Contact: kathy zimmermann ; 25 harbor park drive; port washington, NY 11050-4605 ; 5168019552
• MDR Report Key: 4772817
• MDR Text Key: 15238552
• Report Number: 2647898-2015-00001
• Device Sequence Number: 1
• Product Code: FPB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K850825
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: ELD96LYLS
• Device Lot Number: 502311
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/17/2015
• 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