MAUDE Adverse Event Report: ABBOTT MANUFACTURING INC APS TUBE STORAGE; AUTOMATED PROCESS SYSTEM

Catalog Number 07L07-52

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Injury (2348)

Event Date 10/27/2014

Event Type  Injury  

Event Description

During service of the aps tube storage an abbott field service engineer was injured when the storage shutter cover fell down.The fse was attempting to place the shutter cover back on the instrument when the cover slipped and the injury occured.The injury required 9 stitches on his arm, a tetanus shot and other medication (antibiotics and pain killers).It was indicated that there was no long term adverse impact after receiving treatment.

Manufacturer Narrative

(b)(4).An evaluation is in process.A follow-up report will be submitted when the evaluation is complete.

Manufacturer Narrative

Further evaluation of the issue included a review of the complaint text and photos provided of the shutter cover, a search for similar complaints, a review of the instrument service history and a review of product labeling.Photos provided for review show the cover where one of the protective edge moldings had dislodged when the cover fell and hit the floor, exposing the sharp corner of the side piece; the field service engineer (fse) was not certain what part of the cover caused the injury.The close up photo shows the top piece is bent and is not aligned with the side piece.A spot of blood is visible just below the sharp corner, suggesting the engineer was injured at that spot.This area is normally covered by rubber edge molding.It was concluded that the injury sustained by the engineer was the result of use errors.Review of the instrument service history showed that the rubber edge molding to 6 sharp corners was installed on (b)(4) 2013 in response to a previous issue at this site.The previous investigation identified a deficiency in the reliability of the frame if it became bent through handling, thereby causing a sharp edge.The edge is not sharp as manufactured.The corners of the cover were modified to be rounded starting in (b)(4) 2012.Labeling was reviewed and found to be adequate.Instruction for installation by service personnel directs the employee to wear protective gloves and protective eye wear and complete installation with 2 or more service personnel.The injury was sustained while working independently.Tracking and trending was completed, no other complaints were found noting injuries sustained from the storage panel since the rubber edge molding was installed to existing panels and the rounded covers were manufactured.Based on the available information no product deficiency and no malfunction of the aps tube storage, ln 07l07 was identified.

• Brand Name: APS TUBE STORAGE
• Type of Device: AUTOMATED PROCESS SYSTEM
• Manufacturer (Section D): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer (Section G): ABBOTT MANUFACTURING INC; 1921 hurd drive; irving TX 75038
• Manufacturer Contact: noemi romero-kondos, rn bsn ; 100 abbott park road; dept. 09b9, lccp1-3; abbott park, IL 60064-3537 ; 224667-512
• MDR Report Key: 4255795
• MDR Text Key: 5017075
• Report Number: 1628664-2014-00239
• Device Sequence Number: 1
• Product Code: JQP
• Combination Product (y/n): N
• Reporter Country Code: SA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/27/2014

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: Other
• Device Catalogue Number: 07L07-52
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/03/2014
• Initial Date FDA Received: 11/17/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 12/17/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2008
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 29 YR
• Patient Weight: 100