MAUDE Adverse Event Report: SMITHS MEDICAL ASD, INC., LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET; KZL - BLOOD AND PLASMA WARMING DEVICE

Catalog Number DI-60HL

Device Problem Detachment Of Device Component (1104)

Patient Problem Hypovolemic Shock (1917)

Event Date 07/20/2015

Event Type  Injury  

Manufacturer Narrative

Smiths medical has received the sample device.A full evaluation is anticipated, but not yet begun as the device is currently in transit to the investigation site.Smiths medical will file a follow-up report detailing the results of the evaluation once it is completed.

Event Description

According to reporter, the device was being prepared prior to use with patient.The patient was already in hypovolemic shock.When the device luer was attached to the 3 way stopcock (brand name not provided), the fluid warming set luer became detached from the rest of the set.According to reporter, the patient required resuscitation during this time when an alternate set was prepared.No permanent adverse effects reported.

Manufacturer Narrative

Seven photographs of the complaint product were provided by customer.These photographs showed the level 1 fluid warming set with a detached luer connector and an unattached stopcock (unknown manufacturer).Five samples were returned for evaluation: one of these devices was in used condition and retained the swivel return connector but was missing the luer connector.Examination of the used sample showed the measured dimensions of the swivel return connector were within specifications.Because the detached luer connector was not returned for this sample, no functional testing could be performed with this sample.The manufacturing facility performed an examination of the unused samples.The returned unused samples were all found to meet with specifications (tubing assemblies, swivel return connectors and luer connectors were all assembled as per specifications).Because only a portion of the used complaint device was returned; the root cause could not be definitely established.The manufacturing facility performed an audit of the manufacturing process for this device; this review showed no products with similar luer connector detachment or problems with the assembly process.This review determined that the assembly was being performed as per manufacturing procedure and the products produced were meeting with in-process inspection criteria.The inspection criteria include: visual inspection for voids, dents or cracks; separation force testing and torque verification testing.The investigation could not confirm the reported issue occurred due to an intrinsic device problem.

• Brand Name: LEVEL 1 DISPOSABLE NORMOTHERMIC IV ADMINISTRATION SET
• Type of Device: KZL - BLOOD AND PLASMA WARMING DEVICE
• Manufacturer (Section D): SMITHS MEDICAL ASD, INC.,; rockland MA
• Manufacturer (Section G): SMITHS MEDICAL ASD, INC.,; 160 weymouth st.; rockland MA 02370
• Manufacturer Contact: michele seliga ; 1265 grey fox rd.; st. paul, MN 55112 ; 6516287604
• MDR Report Key: 5008436
• MDR Text Key: 23250077
• Report Number: 2183502-2015-00575
• Device Sequence Number: 1
• Product Code: KZL
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: BK860023
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 08/10/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/28/2018
• Device Catalogue Number: DI-60HL
• Device Lot Number: 2788536
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/03/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 07/29/2015
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention