MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-08-11 for MEDITECH BLOOD BANK RELEASES 5.65, 5.66. 5.67, 6.07, 6.08, 6.14, 6.15 manufactured by Medical Information Technology, Inc. (meditech).
[82838168]
Device available for evaluation: the meditech blood bank software at the customer location is available to meditech staff through a secure vpn connection. The customer site has two separate blood bank databases with the same version of the software: a test database used for research, testing and verification; and a live database used for recording the daily operations of the hospital's blood bank department. Meditech maintains controlled testing environments for the customer version as well as for all versions of the blood bank software. Evaluation of malfunction: after investigating the issue reported by the customer for client server release 5. 66, meditech performed additional on-site and in-house testing and determined that the same issue affects multiple releases of the software. Investigation of the software in meditech's controlled testing environment found that while blood bank spreadsheets use an altered version of the specimen identifier to group multiple crossmatches for one specimen, the originating issue changed this value to allow screen headers to work consistently, which in turn prevented the crossmatch tests from being tracked accurately. If the issue were to recur in a customer's live environment, and the result of a cross-matchable red blood cell product component test is changed by the system, this change could trigger the compatibility calculation and may change the crossmatch compatibility result without any indication to the end user. If the original crossmatch compatible result was calculated with a result of no and it is then changed to yes without a warning to the user, there may be a potential for a patient to receive an incompatible unit of blood. Factors in mitigating risk: the risk to health is low as the changed crossmatch component result is visible to the end user in both the comment box header and the spreadsheet result entry screen. In addition, blood establishments typically re-type units as they come into inventory, as well as, perform physical checks on the blood compatibility such as identifying incompatibility of unit when the blood clots in the test tube, prior to the software issue occurring. However, if this issue were to go unnoticed and a patient received a unit of incompatible red blood cells, the result of this medical error could potentially lead to a transfusion reaction. The preliminary risk analysis conducted indicated the likelihood of the issue occurring was medium. However, further research and analysis determined that the likelihood of the issue actually reaching the patient is low due to the items noted below. The patient would need to have more than 1 red blood cell product order, and their crossmatch would have to be resulted on a blood bank spreadsheet where the comment button was also accessed. The likelihood of this issue going undetected is low for the following reasons: when the crossmatch component test results are the same, the results would change to the same value and the compatible prompt would not be altered. When the crossmatch component results are verified and the end user accesses the spreadsheet to enter a comment, the system displays a warning message to the user indicating that a verified result is being changed. To minimize the risk of potential patient harm, the recommended workaround provides an immediate and strong mitigation for this problem until the identified customer systems with this malfunction receive the software correction. Recommended workaround: users are instructed to use the manual result entry routine rather than the spreadsheet result entry routine. Result comments can be viewed while in the blood bank spreadsheet results using the view footer button, rather than the comment footer button. This issue affects meditech blood bank software releases 5. 65, 5. 66, 5. 67, 6. 07, 6. 08, 6. 14, 6. 15 and 6. 16. Software correction: meditech has modified the software for all releases noted above so that when comments are viewed for crossmatch tests in the blood bank enter/edit spreadsheet results routine, the result of the test is not changed. Meditech has evaluated the device after the correction was made and determined the software is working as intended. The actual software correction is being tracked under (b)(4). Notification and distribution: beginning on july 31, 2017, meditech distributed a notification to customers who have the meditech blood bank software product in either their test or live environment for the releases noted above. This notification was made via e-mailed task updates that can be printed by the customer. Task updates sent via e-mail are immediately transmitted to the customer. Code changes are being provided to all identified customers beginning on august 4, 2017.
Patient Sequence No: 1, Text Type: N, H10
[82838169]
On july 18, 2017, a meditech customer reported that in their live blood bank software environment, an unverified test result had been changed by the system to a different result. A user was entering crossmatch results for a red blood cell product via the blood bank enter/edit spreadsheet results routine. When the user viewed a comment associated to one of the crossmatch component tests, the result of that component test was changed. The customer noticed the result changing on the screen as the problem was occurring and was able to resolve the issue through other means. The customer reported to meditech that they were able to reproduce the issue in their test blood bank software environment. Meditech investigated the reported malfunction and on july 21, 2017, was able to reproduce the issue in meditech's in-house, controlled testing environment. In order for this issue to occur, the patient must have more than 1 crossmatchable red blood cell products on order, and have their crossmatch component tests resulted via a blood bank spreadsheet where the "comments" footer button is accessed. This decreases the likelihood of this issue occurring. If the result of a cross-matchable red blood cell product component test is changed by the system, this change could trigger the compatibility calculation and may change the crossmatch compatibility result without any indication to the end user. If the original crossmatch compatible result was calculated with a result of no and it is then changed to yes without a warning to the user, there may be a potential for a patient to receive an incompatible unit of blood. The issue has been corrected. When comments are viewed for crossmatch tests on red blood cell products in the blood bank enter/edit spreadsheet results routine, the result of the test is not changed. Beginning on july 31, 2017, meditech distributed a notification to all impacted customers via an automated e-mail from our task system (customer service complaint handling tool). Beginning on august 4, 2017, the correction is being delivered to all identified customers. Alternate workflow instructions are provided to customers in an effort to mitigate risk prior to the correction being accepted. To minimize the risk of potential patient harm, the recommended workaround provides an immediate and strong mitigation for this problem until the identified customer systems with this malfunction receive the software correction. Recommended workaround: users are instructed to use the manual result entry routine rather than the spreadsheet result entry routine. Result comments can be viewed while in the blood bank spreadsheet results using the view footer button, rather than the comment footer button. An fda recall/correction report is being initiated for this issue, the correction report number is 3009404844-07/31/17-001-c. This has been submitted to the fda new england district office. No patient harm has been reported due to this issue.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3009404844-2017-00001 |
| MDR Report Key | 6788722 |
| Date Received | 2017-08-11 |
| Date of Report | 2017-08-08 |
| Date Mfgr Received | 2017-07-18 |
| Device Manufacturer Date | 2013-01-22 |
| Date Added to Maude | 2017-08-11 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. MIKE HOCHELLA |
| Manufacturer Street | MEDITECH CIRCLE |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal | 02090 |
| Manufacturer Phone | 7818213000 |
| Manufacturer G1 | MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH) |
| Manufacturer Street | MEDITECH CIRCLE |
| Manufacturer City | WESTWOOD MA 02090 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 02090 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MEDITECH BLOOD BANK |
| Generic Name | MEDITECH BLOOD BANK SOFTWARE |
| Product Code | MMH |
| Date Received | 2017-08-11 |
| Model Number | RELEASES 5.65, 5.66. 5.67, 6.07, 6.08, 6.14, 6.15 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDICAL INFORMATION TECHNOLOGY, INC. (MEDITECH) |
| Manufacturer Address | MEDITECH CIRCLE WESTWOOD MA 02090 US 02090 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-08-11 |