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Catalog Number INS8400
Device Problems Air Leak (1008); Device Operates Differently Than Expected (2913)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Date 06/19/2017
Event Type  malfunction  
Manufacturer Narrative
Sus voluntary event report mw5070545 received. Investigation completed 07/21/2017. Four devices were received on 7/12/2017. The devices received were of lot 1170009. The devices were not in their original packages; one of them still had a catheter attached to it; also, two (2) loose (not attached to any of the devices) transducers were included in the package. The devices were inspected and as stated on the medwatch no cracks or any other observable defect was noticed. The systems were purged with water to see if there were any leaks: none were found. Stopcocks were aligned leaving an open path all the way to the patient line¿s stopcock (proximal) to see if water would backflow in the system: no air was drawn into the system. The air would only get in the system if one (1) of the two (2) stopcocks (patient line or zero reference) was opened. In that case air, would get into the system from the chamber as described in the medwatch. No defect was detected in any of the samples. The described situation is normal for a device without anti-reflux valve and thus the condition is considered confirmed. Device history record (dhr) of lot number 1170009 was reviewed. Manufacturing (packaging) date: january 12, 2017. Expiration date: december 31, 2018. The manufacturing and final pack processes ran normally; no anomalies were found during manufacturing process of the product. This lot complied with different tests performed during manufacturing such as leakage, occlusion, and pull tests; no rejects were reported in any of the tests. Review of product's ncr, and capa history from june 2015 ¿ june 2017: no related ncr or capa was found to have been opened during the period of june 2015 to june 2017. Upon review of integra's complaint system from june 2015 to june 2017, there are four (4) complaints related to ¿air pulling-in the system¿ including this one. Approximately 80,874 units of accudrain external drainage product families and accessories were released for distribution from june 2015 to june 2017. The complaint occurrence rate for this type of incident is 0. 006%. No unusual event related to the reported failure was noticed during the lot records review. The lot complied with all release criteria including functional tests such as leakage, occlusion, and pull tests per tm-1021 (accudrain products functional test). Nothing abnormal was noticed in the returned samples failure analysis. Thus far, only the (b)(6) hospital has complained regarding this issue. Two hundred twenty-three (223) units of lot 1170009 were released to the market. As of july 11, 2017, this lot had already been distributed in over 30 facilities and no complaint has been reported against it from any of the other facilities. Historical data shows that for the last three (3) years (may 2014 ¿ june 2017) (b)(6) hospital has used accudrain catalog ins-8401. Lot 1170009 is the first lot of catalog ins-8400 they have acquired during that time. Their first order for ins-8400 was completely filled with lot 1170009 (next lot was delivered on june 27, 2017). When this event happened on (b)(6) 2017 there was no other ins-8400 lot available at the facility (not until 6/27/2017); therefore, when they changed the accudrain lot number, they changed to an ins-8401, and as reported on the medwatch ¿all problems ceased¿. Ins-8401 and ins-8400 are visually almost identical except that ins-8401 has an anti-reflux valve on the patient line which prevents csf return when there are changes in the patient¿s condition (for example: icp changes, device height, etc. ¿ in this case the complaint description mentions that ¿the movement and amount of air was dependent on the icp¿). Also, it seems that the dr. Was not aware that this catalog (ins-8400) does not include an anti-reflux valve since as stated in the medwatch: ¿dr. Hypothesized that possibly it was some one-way valve that seemed to not be functioning correctly. ¿ thus, it may be concluded that personnel may have not been completely familiarized with the device and that it may behave differently to ins-8401. The customer did not report any leaks in the system and none was observed during the verification of the returned samples. Therefore, it seems that the system behaved as it normally does, but not as the customer expected. This most likely explains why all the units seemed to have the same ¿problem¿.
Event Description
Quantity of accudrain: 2 (same lot number of 1170009). Evd drain was placed in the right lateral ventricle for subarachnoid hemorrhage. When the drain was leveled at the eam (external auditory meatus (foramen of monroe)), the csf inside the drain was pulsating and an air bubble approximately 1. 5 inches long appeared and began moving towards the patient with every pulsation. The resident believed the air may have originated from the burette and stated that the movement and amount of air was dependent on the icp. When the drain was dropped below the level of the eam, csf would drain into the burette briskly. The drain was changed out with another drain and the second drain did the same thing. Both drains were primed with preservative free saline prior to application and the nurse stated was free of bubbles per user facility protocol. Icp's were less than 20 throughout treatment and drains were leveled at the eam and set to a height of 30cm of h20. The nurse and resident confirmed that the stopcock at the bottom of the burette was closed to allow the measurement of draining csf. There was no patient injury reported. Additional information received from the customer on 30jun2017: both drains were switched out for another but once the realization that they were from the same lot number, the customer replaced the second with an accudrain from a different lot number. Patient outcome was reported as patient discharged from hospital to rehabilitation facility. Linked to mfg. Report number: 2648988-2017-00023.
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Type of DeviceN/A
Manufacturer (Section D)
road 402 north, km 1.2
road 402 north, km 1.2
anasco PR 00610
Manufacturer (Section G)
road 402 north, km 1.2
anasco PR 00610
Manufacturer Contact
rowena bunuan
311 enterprise drive
plainsboro, NJ 08536
MDR Report Key6697762
MDR Text Key211626874
Report Number2648988-2017-00022
Device Sequence Number1
Product Code JXG
Combination Product (y/n)N
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/19/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/10/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberINS8400
Device Lot Number1170009
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/12/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/12/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown