MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-08-15 for FLOWTRON EXCEL / TRIO PUMPS manufactured by Getinge (suzhou) Co., Ltd..
[3589851]
(b)(4).
Patient Sequence No: 1, Text Type: D, B5
[11072490]
This report is being filed under exemption (b)(4) by arjohuntleigh, inc on behalf of the manufacturer (getinge (b)(4)). To date, no mdr's have been filed of events caused by the metal eyelet of the warning tag coming into contact with an electrical outlet. Globally, in the past 5 years we have reported 7 mdrs relating to incidents of electric shock from damaged power cables. Of those 7 events, only minor shocks were recorded with no serious injury obtained; mdr# 100381138-2011-00017, 00019, 2010 - mdr # 1000381138-2010-00009, mdr# 1000381138-2011-00015, mdr# 1000381138-2011-00004, 00007, 00011. All of the above mdrs were reported against our pac (pressure cables, of which none have resulted in serious injury or death. A review of scrap and rework history was performed to detect relevant trends. This review did not provide any relevant information with regards to this complaint. The product's dhr was reviewed for anomalies. The dhr review did not show any anomalies. The product's recall history was reviewed for links with the complaint description. This review did not provide any relevant information with regards to this complaint. The information provided by the facility in the form of an idf (incident description form) and pictures confirmed that the warning tag fitted to the main's cable had been removed from the pump unit and the metal eyelet remained. Evidence suggests that the eyelet did suffer a short of some kind, enough to potentially cause a shock. It is difficult to determine how the eyelet came into contact with the mains supply as our products are fitted with medical graded transparent plugs, yet not impossible. We can confirm that this type of incident has never been reported to us (ah) before and appears isolated. The risk analysis of the flowtron excel does cover electrical hazards (inc. Electric shock). The risk associated to electric shock is deemed serious and therefore reportable to the authorities. The "flowtron excel" risk analysis document. A root cause analysis was performed. Based on the evidence provided, we can be clear that the event was caused by a combination of unforeseen circumstances and failings: failure to adequately inspect the devices mains plug prior to connecting to the facilities power socket. Failure to completely remove the hazard (metal eyelet) from the device and/or replace with new warning label prior to use. The metal eyelet becoming lodged between both ground and live plug points (improbable). With the occurrence of harm being improbable in relation to this event, we do not recommend any further action is required in this case. (b)(4). We have not been able to duplicate the failure modes related to this type of complaint. On its own, the metal eyelet does not pose any immediate risk. We have not been able to establish a complaint trend with this product and issue and see this as an isolated incident. We have not been able to find any contributing manufacturing anomalies. We find this complaint to be safety related, and reportable to the competent authorities based on the risk relating to 'electric shock'. The device did not meet its specifications. The device was being used for patient treatment at the time of the event. We (arjohuntleigh) monitor all types of events to ensure any form of trend is captured and reviewed periodically.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3005619970-2013-00009 |
| MDR Report Key | 3307755 |
| Report Source | 06 |
| Date Received | 2013-08-15 |
| Date Mfgr Received | 2013-07-17 |
| Date Added to Maude | 2013-08-27 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 0 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Street | 2349 WEST LAKE ST. |
| Manufacturer City | ADDISON IL 60101 |
| Manufacturer Country | US |
| Manufacturer Postal | 60101 |
| Manufacturer Phone | 8003231245 |
| Manufacturer G1 | GETINGE (SUZHOU) CO., LTD. |
| Manufacturer Street | NO. 158 FANGZHOU ROAD, SIP |
| Manufacturer City | SUZHOU, JIANGSU 215024 |
| Manufacturer Country | CH |
| Manufacturer Postal Code | 215024 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | FLOWTRON EXCEL / TRIO PUMPS |
| Product Code | KNM |
| Date Received | 2013-08-15 |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GETINGE (SUZHOU) CO., LTD. |
| Manufacturer Address | NO. 158 FANGZHOU ROAD, SIP SUZHOU, JIANGSU 00002150 CH 000021502 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-15 |