MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2020-02-27 for ZOLL IVTM THERMOGARD XP 8700-0650 manufactured by Zoll Circulation.
[184471696]
The reported complaint of "the thermogard xp ivtm system (sn (b)(4)) displayed tcmid:01 (pump failed) error message" was confirmed during the functional testing and based on the event log review. The root cause for the reported error was due to the loose solder contact on the motor drive board which connects to the pump. Upon visual inspection, no physical damage was observed. During functional testing, the pump failed to rotate and caused "pump failure" alarm. The event log review showed occurrence of tcmid:01 (pump failed) error message on the reported event date. During functional testing, the cause for the pump failure was found to be due to loose solder contact on the motor drive board. The contacts were re-soldered to address the tcmid:01 error. Following service, the thermogard xp ivtm system passed the final testing without any error. Historical complaints were reviewed for service information related to the reported complaint and there was no similar complaint reported for thermogard xp ivtm system with sn (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[184471697]
During patient treatment, the cooling phase of the ivtm therapy was completed using the thermogard xp ivtm system (sn (b)(4)) without any interruptions. Upon initiation of the warming phase, the user noticed saline leak from the flow indicator of the start-up kit (suk) #1 (lot # 094301). The dwell time of the suk #1 was 24 hours. Immediately, the user replaced the leaking suk #1 with suk #2 (lot # 098473) and noticed saline leak from the flow indicator of the suk #2. In addition the user noticed that the ivtm system displayed an unknown error message. The user observed empty saline bag and saline traces on the floor. The user replaced the leaking suk #2 with suk #3 and the patient treatment was continued using another thermogard xp ivtm system. Per event log review, the unknown error message observed by the user was tcmid:01 (pump failed). No consequences or impact to patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3010617000-2020-00175 |
| MDR Report Key | 9764384 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2020-02-27 |
| Date of Report | 2020-02-27 |
| Date of Event | 2020-02-03 |
| Date Mfgr Received | 2020-02-03 |
| Device Manufacturer Date | 2016-11-21 |
| Date Added to Maude | 2020-02-27 |
| 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 | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. KIM NGUYEN |
| Manufacturer Street | 2000 RINGWOOD AVE, |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Manufacturer Phone | 4192922 |
| Manufacturer G1 | ZOLL CIRCULATION |
| Manufacturer Street | 2000 RINGWOOD AVE. |
| Manufacturer City | SAN JOSE, CA |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ZOLL IVTM THERMOGARD XP |
| Generic Name | THERMAL REGULATING SYSTEM |
| Product Code | NCX |
| Date Received | 2020-02-27 |
| Model Number | 8700-0650 |
| Catalog Number | 8700-0650 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | ZOLL CIRCULATION |
| Manufacturer Address | 2000 RINGWOOD AVE. SAN JOSE, CA US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-27 |