CASSETTE MEDI RESERVOIR
Received Jul 30, 2026
Report MW6000151 · MDR key 50086311
Device
Generic name
Set, I.v. Fluid Transfer
Lot number
UNK
Product problems
- Biocompatibility
- Therapeutic or Diagnostic Output Failure
Patient
Male
- Insufficient Information
Narrative
Description of Event or Problem
pt reported 2 cassette medi reservoirs had broke causing solis pump to alarm. ptconfirmed they were able to create another cassette to continue infusion and pump isworking as expected. pt has 7 cassettes on hand. pump serial number and expirationunknown. no further information, details or dates available. pump return trackinginformation is not available. photographs were not provided. position of pump whenalarm occurred is unknown. this is a continuous infusion. set flow rate and volumedelivered are unknown. product lot and expiration unknown. unknown if md is aware.dose amount: remodulin mdv - 169ng/kg/min. iv remodulin pt via cadd solis pump. did the reported product fault occur while in use with pt? - yes. did the product issuecause or contribute to pt or clinical injury - no. is the actual device available forinvestigation? - unknown. did pharmacy replace device? - unknown. did the pt have abackup device they were able to switch to? - unknown. is the infusion life-sustaining? -yes outcome? - unknown. Patient Code: 4582. Health Effect Code: 4629. Device Code: 3023. Device Component Code: 934. Reference Report#: CDRH-50087258. This report captures Cassette Medi Reservoir.