MAUDE Adverse Event Report: RADIOMETER MEDICAL APS SAFEPICO

Catalog Number 956-614

Device Problems Detachment Of Device Component (1104); Use of Device Problem (1670); Compatibility Problem (2960); Pressure Problem (3012)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Date 01/01/2016

Event Type  malfunction  

Manufacturer Narrative

Device discarded by customer.

Event Description

According to the customer, after taking the sampler out of the cup with ice slurry the tip cap "literally blew off the syringe so hard that blood ended up on the stat lab ceiling".According to the customer the staff is trained to use the safepico and the instructions for use was followed.The patient sample had to be recollected as all blood was shot out of the sampler.Nobody came into contact with the blood.The sampler was discarded after the event and the customer has no information of the lot number for the safepico.

Manufacturer Narrative

The following statement is included in the ifu: "storage should be avoided whenever possible or at least kept to a minimum.If it not possible to analyze the sample immediately, store it at room temperature and analyze it within 30 minutes after collection." according to the customer, the sampler had been stored in an ice slurry just before the event.This is to prevent degradation of the sample for lactate and glucose if sample analysis time is >10 minutes after sample draw.A potential root cause to this event could be inappropriate handling of the blood sample and sampler itself, but this has not been confirmed.

Manufacturer Narrative

It has been concluded that the root cause to the problem most likely was inappropriate handling of the blood sample and sampler itself.

• Brand Name: SAFEPICO
• Type of Device: SAFEPICO
• Manufacturer (Section D): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer (Section G): RADIOMETER MEDICAL APS; åkandevej 21; brønshøj, 2700 ; DA 2700
• Manufacturer Contact: tom engdahl ; åkandevej 21; brønshøj, 2100 ; DA 2100 ; 538273827
• MDR Report Key: 5999805
• MDR Text Key: 57322313
• Report Number: 3002807968-2016-00035
• Device Sequence Number: 0
• Product Code: FMI
• Reporter Country Code: CA
• PMA/PMN Number: K043143
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 03/09/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 956-614
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/28/2017
• Was Device Evaluated by Manufacturer?: No
• 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