MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a health professional,user faci report with the FDA on 2019-01-04 for PFA-100 SYSTEM 10444868 manufactured by Siemens Healthcare Diagnostics Products Gmbh.
[132789666]
The customer contacted a siemens customer care center and reported that collagen/epinephrine (col/epi) and collagen/ adenosine-5'-diphosphate (col/adp) results, obtained on four patient samples, were flagged with "maximum test time exceeded" on a pfa-100 system. Siemens discussed the handling of samples with the customer and the customer reported that samples are hand delivered according to their protocol. The customer reported that self tests are run on the system each day and that the tests recovered acceptably each day. The customer also indicated that they run quality controls (qcs) once a month, and qcs recovered within acceptable ranges on (b)(6) 2018. The customer repeated the samples using other reagent cartridges and the same results were obtained; the customer did not provide these results. As per the pfa-100 system instructions manual, when "maximum test time exceeded" is triggered and the non-closure result does not agree with the patient's clinical condition, there is a potential vacuum leak. The operator should "perform a self test via the maintenance menu without loading the cleaning pad. If the vacuum leak test fails, perform the manual o'ring maintenance procedure via the maintenance menu and rerun the self test. " the operator should also repeat the sample using a new pfa test cartridge to verify the test result. The customer did not indicate whether they repeated the sample prior to reporting ">300 seconds". The customer did not provide the dates in which the flagged results were obtained, and therefore, was intentionally left blank. The customer also did not provide patient data to support the issue that they reported to siemens. Siemens is investigating the issue.
Patient Sequence No: 1, Text Type: N, H10
[132789667]
The customer indicated that during a two week period, flagged collagen/ epinephrine (col/epi) and collagen/adenosine-5'-diphosphate (col/adp) results were obtained on four patient samples on a pfa-100 system. The customer reported these results as ">300 seconds" to the physician (s) and based on these results, the patients were transfused with platelets. The patients were sent to an alternate laboratory, where their blood was redrawn. The new samples were run at the alternate laboratory and the results recovered within normal ranges. The repeat results were reported, as the correct results, to the physician(s). There are no known reports of adverse health consequences due to flagged col/epi and col/adp results.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9610806-2019-00001 |
| MDR Report Key | 8216954 |
| Report Source | HEALTH PROFESSIONAL,USER FACI |
| Date Received | 2019-01-04 |
| Date of Report | 2019-01-22 |
| Date Mfgr Received | 2019-01-08 |
| Date Added to Maude | 2019-01-04 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | CHRISTINA LAM |
| Manufacturer Street | 511 BENEDICT AVE |
| Manufacturer City | TARRYTOWN NY 10591 |
| Manufacturer Country | US |
| Manufacturer Postal | 10591 |
| Manufacturer Phone | 9145243504 |
| Manufacturer G1 | BIT ANALYTICAL INSTRUMENTS GMBH |
| Manufacturer Street | REGISTRATION NUMBER:3003601075 AM KRONBERGER HANG 3 |
| Manufacturer City | SCHWALBACH 65824 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 65824 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | PFA-100 SYSTEM |
| Generic Name | PFA-100 SYSTEM |
| Product Code | JOZ |
| Date Received | 2019-01-04 |
| Model Number | PFA-100 SYSTEM |
| Catalog Number | 10444868 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SIEMENS HEALTHCARE DIAGNOSTICS PRODUCTS GMBH |
| Manufacturer Address | EMIL-VON-BEHRING- STR. 76 MARBURG, D-35041 GM D-35041 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2019-01-04 |